MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-09 for ALTERNATING PRESSURE MATTRESS W/LOW AIR LOSS, 36 X 80 X 10, 50L 9153647225 NA:MA65 MA65 manufactured by Kap Medical.
[174726068]
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.
Patient Sequence No: 1, Text Type: N, H10
[174726069]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1531186-2020-00001 |
| MDR Report Key | 9570295 |
| Date Received | 2020-01-09 |
| Date of Report | 2019-12-10 |
| Report Date | 2020-01-20 |
| Date Reported to FDA | 2020-01-20 |
| Date Reported to Mfgr | 2020-01-20 |
| Date Mfgr Received | 2020-01-20 |
| Device Manufacturer Date | 2017-12-01 |
| Date Added to Maude | 2020-01-09 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ALTERNATING PRESSURE MATTRESS W/LOW AIR LOSS, 36 X 80 X 10, 50L 9153647225 |
| Generic Name | MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE |
| Product Code | FNM |
| Date Received | 2020-01-09 |
| Model Number | NA:MA65 |
| Catalog Number | MA65 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | 2 YR |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KAP MEDICAL |
| Manufacturer Address | 1395 PICO ST CORONA CA 92881 US 92881 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-01-09 |