MAUDE Adverse Event Report: KAP MEDICAL ALTERNATING PRESSURE MATTRESS W/LOW AIR LOSS, 36 X 80 X 10, 50L 9153647225; MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE

Model Number NA:MA65

Device Problem Deflation Problem (1149)

Patient Problem Pressure Sores (2326)

Event Type  Injury  

Manufacturer Narrative

This complaint is being filed in an abundance of caution.The dealer advised the end-user is bed bound and is currently still using mattress in a private home.Technicians tested the mattress and no leaks were found.Based on the limited information provided, a device malfunction cannot be confirmed.The complaint could not be verified, and the underlying cause could not be determined.Should additional information become available, a supplemental record will be filed.

Event Description

The end-users wife called and advised that her husband has bed sores on his backside due to the ma65 mattress not working properly.The dealer advised that the end-user is receiving wound care of cleaning, debridement, irrigation, and lidocaine for pain.

Manufacturer Narrative

The control unit was returned for an expanded evaluation.Utilizing existing complaint information, actual observations, and functional testing of the returned product in its ¿as received¿ condition, the complaint was not confirmed for the mattress not fully inflating.Upon receipt the cpr valve was open.The cpr valve was closed, utilizing the control unit the mattress fully inflated and functioned with alternating pressures as designed.The malfunction reported is consistent with the cpr valve being left open.

Event Description

The end-users wife called and advised that her husband has bed sores on his backside due to the ma65 mattress not working properly.The dealer advised that the end-user is receiving wound care of cleaning, debridement, irrigation, and lidocaine for pain.

• Brand Name: ALTERNATING PRESSURE MATTRESS W/LOW AIR LOSS, 36 X 80 X 10, 50L 9153647225
• Type of Device: MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE
• Manufacturer (Section D): KAP MEDICAL; 1395 pico st; corona CA 92881
• MDR Report Key: 9570295
• MDR Text Key: 174726068
• Report Number: 1531186-2020-00001
• 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: 01/20/2020,12/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: NA:MA65
• Device Catalogue Number: MA65
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/20/2020
• Device Age: 2 YR
• Event Location: Home
• Date Report to Manufacturer: 01/20/2020
• Date Manufacturer Received: 01/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 67