FDA Adverse Event
Malfunction
Summary report: N
APOLLO 3 PORT
MDR report key: 1902922
·
Received November 12, 2010
Report
- Report Number
- MW5018211
- Event Type
- Malfunction
- Date Received
- November 12, 2010
- Date of Event
- November 12, 2010
- Report Date
- November 12, 2010
- Manufacturer
- APOLLO 3 PORT WOUND CARE MANAGEMENT SYSTEM
- Product Code
- INX
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- NC, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
BLUE CHIP-APOLLO 3 PORT WOUND CARE SYSTEM PUMP MALFUNCTION CAUSING THE MATTRESS TO DEFLATE AND RESIDENT SLID TO BOTTOM OF BED AND OUT OF THE BED. NO INJURY RESULTED FROM THE FALL BUT THE PUMP DID CAUSE THE CIRCUIT BREAKER TO TRIP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | APOLLO 3 PORT | BLUE CHIP | INX | APOLLO 3 PORT WOUND CARE MANAGEMENT SYSTEM | 17078887 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 76 YR | Other |