FDA Adverse Event
Malfunction
Summary report: N
KCI ATMOS AIR
MDR report key: 4368596
·
Received December 22, 2014
Report
- Report Number
- MW5039824
- Event Type
- Malfunction
- Date Received
- December 22, 2014
- Date of Event
- December 16, 2014
- Report Date
- December 22, 2014
- Manufacturer
- KCI
- Product Code
- INX
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Description of Event or Problem · 1
AIR MATTRESS PUMP FAILED. NEWLY FORMED WOUND-SKIN DENUDED/ABRASION FOUND ON D/C. NEW WOUND ON RIGHT BUTTOCK. MATTRESS PLUGGED IN, BUT WAS NOT POWERED DUE TO LOOSE WIRE INSIDE PUMP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 843097 | KCI ATMOS AIR | AIR MATTRESS | INX | KCI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 79 YR |