MAUDE Adverse Event Report: KAP MEDICAL TRUE LOW AIR LOSS 42 IN BARIATRIC SIZE 9153649544; MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE

Model Number MA80B42

Device Problem Fire (1245)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/26/2017

Event Type  malfunction  

Manufacturer Narrative

The dealer was not aware if the end user was in the bed at the time of the fire.No injury or property damage occurred.The dealer stated that the end user did not allege that there was any indication of heat within the power unit prior to the reported incident.The dealer was not aware if the unit was plugged into a wall outlet or a power strip.The dealer was not aware of the frequency with which the filters were cleaned but stated that based on the cleanliness of the home, he would imagine that they were cleaned regularly.Multiple attempts were made to contact the end user for further information without success.The product has not been returned for evaluation.The complaint could not be verified, and the underlying cause could not be determined.The ma80b42 mattress was manufactured in november 2014; therefore, it has exceeded its expected life of 2 years.Should additional information become available, a supplemental record will be filed.

Event Description

The dealer stated that the power unit had a fire.The dealer stated that the rear filter on the power unit was singed off, allowing the flames to be visible through the grates of the filter, but the flames were contained within the power unit.

Manufacturer Narrative

The following additional information was provided by the dealer: the unit was begin used under normal operating conditions in the patient's home.The unit was operating properly prior to the incident; the patient did not experience any unusual operation or behavior.The patient's exact weight was not obtained, but the dealer reported that he requires a bariatric device.The dealer did not observe the reported incident; the patient and his family allegedly observed the unit smoking and then a small fire inside the unit.The patient's family said the filter was damaged; however, the filter was not returned to the dealer.The unit is currently being quarantined by the dealer and will not be returned to invacare at this time.An invacare representative evaluated the unit onsite and provided pictures which show no indications of fire or smoke damage to the exterior of the unit.

• Brand Name: TRUE LOW AIR LOSS 42 IN BARIATRIC SIZE 9153649544
• Type of Device: MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE
• Manufacturer (Section D): KAP MEDICAL; 1395 pico street; corona CA 92881
• MDR Report Key: 6446957
• MDR Text Key: 71287248
• Report Number: 1531186-2017-00005
• Device Sequence Number: 1
• Product Code: FNM
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date: 05/05/2017,02/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MA80B42
• Device Catalogue Number: MA80B42
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/05/2017
• Distributor Facility Aware Date: 04/12/2017
• Device Age: 2 YR
• Event Location: Home
• Date Report to Manufacturer: 05/05/2017
• Initial Date Manufacturer Received: 03/30/2017
• Initial Date FDA Received: 03/30/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/05/2017
• Date Device Manufactured: 11/01/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1