FDA Adverse Event
Malfunction
Summary report: N
TEMPO
MDR report key: 2931786
·
Received December 26, 2012
Report
- Report Number
- 2931786
- Event Type
- Malfunction
- Date Received
- December 26, 2012
- Date of Event
- December 26, 2012
- Report Date
- December 26, 2012
- Manufacturer
- ARJOHUNTLEIGH, INC.
- Product Code
- FSA
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- VA, US
Narratives
Description of Event or Problem · 1
BATTERY PACK OVERHEATED, PRODUCING CHEMICAL ODOR. FIRE RESPONSE WAS CONTAINED TO AN EQUIPMENT ROOM AND ACUTE CARE UNIT. ALARMS WERE GOING OFF FOR ABOUT 45 MINUTES ON SEVERAL FLOORS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TEMPO | PATIENT LIFT, BATTERY | FSA | ARJOHUNTLEIGH, INC. | TEMPO | 0802 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * | NO OTHER THERAPIES | ||
| 2 | * |