MAUDE Adverse Event Report: UNKNOWN INVACARE CAREGUARD APP ALTERNATING PRESSURE PAD SYSTEM; MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE

Model Number CG9701

Device Problem Insufficient Information (3190)

Patient Problem Death (1802)

Event Date 12/25/2017

Event Type  Death  

Manufacturer Narrative

This mdr is being filed out of an abundance of caution.Invacare received an allegation that an electrical malfunction of the cg9701 pump caused a fire which resulted in a death.This allegation has not been confirmed, and there is insufficient information available to classify a device problem.Invacare was not made aware of the incident until almost a year after it occurred.Invacare did not have the opportunity to evaluate the device following the incident, and it is unknown if the device was preserved and is still available to be evaluated.Invacare also did not have an opportunity to be a part of any onsite investigations into potential causes of the fire, and (b)(6) advised that the insured's home has already been repaired.Multiple requests have been made to allow invacare to examine any police/fire reports that may have been completed at the time of the event, as well as (b)(6) investigation into the incident.The serial number of the product was not available, so the manufacturer and age of device could not be determined.Should additional information become available, a supplemental record will be filed.

Event Description

A letter was received from a (b)(6) claims person alleging that a fire started from an electrical issue with the pump on a cg9701 alternating pressure system.The fire caused damage to the insured's home and death to an individual who was staying with the insured under hospice care.

Event Description

A letter was received from a state farm claims person alleging that a fire started from an electrical issue with the pump on a cg9701 alternating pressure system.The fire caused damage to the insured's home and death to an individual who was staying with the insured under hospice care.

Manufacturer Narrative

On (b)(6) 2019, invacare received the fire marshal¿s report of the incident.The report stated that the fire originated in the room where the patient resided.It was noted that he was an alzheimer's patient who was bedridden and could not care for himself.Upon performing a scene examination, it was observed that the patient's hospital bed was heavily damaged by fire.The fire had burnt the middle of the bed and went downward toward the bottom of the bed.A large amount of plastic-looking debris was found under the bed, which appeared to be the same material that was found on the bed from some type of mattress pad.The underside of the bed (motor and frame) showed fire damage on top, due to fall down from the mattress and other items on the bed, but there was no damage on the bottom.The motor showed no signs of arcing or melting.The electrical outlets in the room were checked, and they showed no signs of damage.No extension cords were found going to the bed.After looking at the bed and the scene, it was determined that a possible malfunction of some device on top of the bed may have been the cause of the fire.The fire investigators then interviewed the witnesses and home owner, who indicated that they all smelled and saw the fire.One of the witnesses advised that when he entered the room, he saw that the fire was on the patient's bed, but he could not get the patient out of the room due to the smoke and heat.The home owner advised that the patient's medical equipment was provided by hospice, including an app (alternating pressure pad) that they had placed on the patient's bed.The witnesses stated that the patient was incontinent and had to wear diapers and have pads placed under him, but it could not be verified whether any of these were being used at the time of the incident, due to the amount of fire and the patient being transported to the hospital.When the investigators arrived at the hospital, they were advised that the patient had died.They examined the body and found that the patient had sustained severe burns on his buttocks, back of his legs, and feet.Due to the burn patterns on the bed, the device that was melted on the floor, and the area of burn on the victim, the fire marshal concluded that something may have malfunctioned or failed on the cg9701 app device that was on the bed, but this could not be definitively determined.Ultimately, the case was ruled accidental.Note: in the initial report, the incorrect patient information was provided, so it has been updated with the correct information.

• Brand Name: INVACARE CAREGUARD APP ALTERNATING PRESSURE PAD SYSTEM
• Type of Device: MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 8239726
• MDR Text Key: 132794393
• Report Number: 1531186-2019-00001
• Device Sequence Number: 1
• Product Code: FNM
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup
• Report Date: 01/11/2019,12/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: CG9701
• Device Catalogue Number: CG9701
• Was the Report Sent to FDA?: No
• Date Report Sent to FDA: 01/11/2019
• Distributor Facility Aware Date: 12/14/2018
• Event Location: Home
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 78 YR