FDA Patient Safety | Home Use Devices | Case Studies | Regulatory Doctor

FDA Patient Safety | Home Use Devices | Case Studies | Regulatory Doctor

The FDA encourages consumers and health care professionals to report problems they have with their devices while they are using them. This could be anything from an injury or death to a malfunction or near miss with a device while it is being used. Users should report these problems to the FDA so that we can accumulate information on products in our national database and take any action if needed. The reporting number you should use is 1-800-FDA-1088.


Case Study for December 2012: Night fire

During the night, a patient woke up to his CPAP (Continuous Positive Airway Pressure) on fire. He quickly jumped up and unplugged the unit from the wall outlet which extinguished the flame. Unfortunately the patient disposed the device before the manufacturers could inspect the device.

Case Study for November 2012: Fire on the sofa

A patient was sitting on a therapeutic cushion on the sofa while smoking. The sofa suddenly caught fire and the patient screamed for help. Luckily he was on intercom with his caregiver neighbor while this incident begun. She sprinted to his house and tried putting the fire out by wetting a towel and rolling him on the floor. The patient was transferred to a nearby hospital. Thirty percent of his body suffered from severe burns. Unfortunately, the patient died nine days after the fire incident.

Case Study for October 2012: Failed Infusion Pump Alarm

A nine year old girl was using an infusion pump to manage her diabetes. She was using an insulin infusion pump set that was discarded from the hospital. The patient got her catheter changed on the first of June. Soon after, she experienced nausea and vomiting that evening and was sent to the emergency room the next morning. The girl was conscious when she arrived at the hospital. The catheter was immediately removed and medical professionals discovered a bent cannula. The infusion pump never alarmed to inform any changes. The child died the next afternoon due to heart failure.

Case Study for September 2012: Humid fire

A man reported that his humidifier burst into flames after 15 minutes of usage. Luckily the man was not hurt through this incident.

Case Study for August 2012: Allergic instrument

A laboratory employee experienced an allergic reaction when he came in contact with an immunoassay system. He instantly broke out in a rash and experienced respiratory distress due to his severe allergies. He was immediately transported to the hospital and received Epi Pens.

Case Study for July 2012: Cold fine print

A patient was given a reusable instant cold pack when she had surgery and placed it back in the freezer when she was finished with using it. The next morning, she took it out of the freezer to use on her arthritic knee. She didn’t feel a thing when she used it. But when she took of the freeze pack, she noticed that her leg was burned on blistered. She went to the doctor and was informed she got a third degree burn on her knees. She said that when she read “reusable” on the front of the pack, she automatically assumed she should place it in the fridge after use. Unfortunately, she failed to notice the fine print at the bottom of the package that says “Do Not Freeze.”

Case Study for June 2012: Sever Frost Bite
After an outpatient surgery with fusion and deep peroneal nerve burial on the patient’s right foot, he was provided with a cold therapy unit prior to his discharge. He was instructed to use the unit continuously. A few days after, the patient experienced severe pain and chills on his foot and was sent to the emergency room. The medical team tried all sorts of methods to treat his foot, but it was too late. The patient had to have four of his toes and part of his foot amputated.

Case Study for May 2012: Tragedy with Oxygen Therapy
A patient receiving oxygen therapy at home was cooking in the kitchen with his therapy equipment on. Through a series of unexpected events, an explosion erupted in the kitchen and fire spread throughout the house. The patient was killed in the explosion.

Case Study for April 2012: Fire in the bed
An elderly patient was bedridden to a remote control hospital-type bed. Due to electrical wiring complications, a fire was ignited and the patient was stuck in the bed. The patient later suffered from severe burns and died as a result of the fire.

Case Study for February 2012: Cold Burn
A patient was having trouble with her liquid oxygen portable tank. The liquid oxygen tank would freeze the outside of her insulated bag. As a result, the patient suffered from burns that needed to be treated by a plastic surgeon.

Case Study for March 2012: Blackout
A patient’s CPAP machine stopped working completely when his community experienced a blackout due to severe winds. The device had to be removed and the power had to be completely resorted before the device could work again.

Case Study for January 2012: Spontaneous Wheelchair Combustion
After driving his scooter outside, the patient decided to park it on his deck. About a half hour later, the scooter caught on fire. The patient quickly tried to extinguish the fire by pouring water over it. After this event, the patient had to seek medical attention due to an anxiety attack.

Case Study for December 2011: Deadly tampon
The patient was using a regular absorbency tampon, when she went into toxic shock syndrome. She was admitted to the hospital with dehydration, vomiting, fever, and kidney failure. The patient died as a result of adult respiratory distress syndrome, sepsis, rash, and heart failure.

Case Study for November 2011: Burning cramps
A woman was using heat wraps to alleviate menstrual cramps. The patient used these heat wraps for 6 hours, and when they were removed, she noticed two quarter sized red patches on her lower abdomen. These patches began itching and her skin bubbled up. The patient had to treat the patch burns for a month after the incident occurred because it resulted in a 3rd degree burn.

Case Study for October 2011: The deadly alarm
A young patient had a heart monitor that had the ability to alarm his parents when his heart rate was slowing down. In the middle of the night, the monitor alarmed and woke the parents, but the timing was too late. The monitor alarmed when the patient had stopped breathing entirely. Tragically, the young patient passed away.

Case Study for September 2011: Slippery Wheelchair
A Home Health Services Physical Therapist reported that a patient fell while being transferred into and out of her new wheelchair. The patient explained that the wheelchair slid away from her. She noticed that the wheelchair brakes were inadvertently unlocked by the leg rest when she tried to swing them out of her way to sit. Her physical therapist tried to adjust the leg rests into a position that would avoid contact with the brake handle but was unable to. The same problem occurred when a second wheelchair was delivered to the patient. Home Health Services later learned that the push locks on this specific wheelchair could be disengaged by the elevating leg rests when swung completely open. The elevating leg rest could not be moved into a position that would avoid contact with the handle on the push to lock the brakes.

Case Study for August 2011: Strangling Strap
A 5 year-old girl with cerebral palsy was watching TV while sitting strapped into her stroller. The girl had moved from the original upright position in a way that loosened the straps on her chest and pelvis. The girl then proceeded to slip forward in the chair which caused the strap to put pressure on her neck. Her sister discovered her, and observed that the strap was caught around her neck. The young girl was immediately taken to the hospital. Unfortunately, after a series of events, she died one week later.

Case Study for July 2011: Dangerous Purchase
A consumer ordered a knee walker/leg caddy from an online shopping website. This device was unsuitable and even dangerous because the knee platform was unsteady and the pads were slick. The steering did not turn 120 degrees as advertised, the brake did not work well, and the handlebars collapsed (weight was not a factor). As a result, the consumer experienced a fall. At first, the online seller refused a refund, but the buyer appealed to PayPal and PayPal secured a full refund on the basis that the device was unsafe and not as described. The consumer later learned that this device was an imitation to a superior product. This cheaply-made imitation is extremely dangerous and could further injury and/or result in additional surgery for many people. Unfortunately, the imitation is still being sold on the shopping website.

Case Study for June 2011: Poor Integrity Leading to Fall
A patient was being transferred from his hospital bed to the shower using a lift with a sling. While he was being transferred, the gray connector clip on the sling snapped in half, causing the patient to topple to the ground. The nursing staff observed that the sling experienced multiple washings which contributed to the poor integrity of the clip.

Case Study for May 2011: A Powerful Sneeze
While the patient was sneezing, his hand accidently pressed the speed button on his wheelchair. As a result, his power wheelchair shot forward with his arm fully extended. The patient was rammed into his TV and broke the glass door on the TV stand. A physical therapist was present at the event, and noted that the joy stick was close in proximity to the speed button. Due to the placement of the speed button, it was extremely easy to accidently increase the wheelchair speed while operating the joy stick.

Case Study for April 2011: Fatal Feeding
After a power surge that occurred in the morning, a baby’s feeding pump was reset from 30 ml to 300ml/hour feeding rate. It is unclear whether the feeding pump was plugged into an electrical outlet at the time of the power surge. The grandmother noticed the change, yet didn’t know what it meant so she continued to feed and input formula until the bag was empty. As a result, the baby was overfed. After the baby had been born, the mother, grandmother, and a Spanish interpreter were taught by the charge nurse on how to use the feeding pump. In fact, they had received teaching sessions 24-48 hours prior to the baby’s initial discharge from the hospital. When they discovered the ill and motionless baby, the mother immediately rushed the baby to the ER. The baby had apparent respiratory ailments. The mother estimated that the pump was running at 300ml per hour for approximately 2 hours. During the check up, it was discovered that the baby was suffering from necrotic bowel situation and a large amount of enteral formula was found in the stomach. As a prior condition, the baby was born with a congenital heart defect. Sadly, the baby died shortly after.

Case Study for March 2011: Roasting Patch
A 70 year old woman started using two pain relieving heat patches to treat her lower back pain. The following day, her husband, daughter, and caregiver noticed redness and burns on the area of her skin where she applied the patch. In response, she applied bacitracin cream to ease the symptoms and stop the burning. The cream did not prove to be effective so she ended up getting hospitalized for burn. The woman was discharged from the hospital five days after the incident. Her skin, where the patch was applied, ended up peeling off her back.

Case Study for February 2011: Hot Seat
A man laid waiting in bed to be transferred into his power wheelchair by his brother. His brother walked over and unplugged the 12 volt charger that was connected to the battery in the base of the chair which provides power to the man’s ventilator. Instantly, a fire erupted from underneath the seating system. The man’s brother, and later, his wife whom rushed to the scene, immediately sprayed the wheelchair with a fire extinguisher, but the fire continued to burn. In quick reaction, the brother and wife detached the backpack and ventilator from the back of the chair and continued to spray it with a fire extinguisher. They had to roll it outside because the bedroom and entryway were full of smoke. The fire continued to last for approximately one minute before dying out.

Case Study for January 2011: Charged Car
A 40 year old father had just had an implantable cardiodefibrillator (ICD) placed in the week before. The ICD was working well and he was not experiencing any problems. After healing for a week, the father decided to play with remote controlled cars with his son. Initially while he was standing and playing with the cars, the father did not sense any problems. However, when the father lay down on the ground and the son started to drive the remote controlled car over his father’s chest, the ICD would beep. Even though the son found this funny, the father got up and stopped playing with the remote controlled cars. He reported this to his physician even though he didn’t have any further complications.

Useful Links

Source:  FDA

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