FDA Adverse Event
Malfunction
Summary report: N
TEMPO PPP
MDR report key: 942803
·
Received November 13, 2007
Report
- Report Number
- 9617021-2007-00051
- Event Type
- Malfunction
- Date Received
- November 13, 2007
- Date of Event
- September 17, 2007
- Report Date
- November 13, 2007
- Manufacturer
- ARJO MED AB LTD.
- Product Code
- FSA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
THE FACILITY REPORTS, AT APPROX 4:30 PM, THE CNA WAS LOWERING THE PT ONTO THE BED WHEN THE SPREADER BAR CAME OUT OF THE JIB SOCKET, DROPPING THE PT ONTO THE BED. THE SPREADER BAR FELL ON TOP OF THE PT'S LEFT FOREARM, UPPER LEFT SHOULDER, AND RIGHT LOWER LEG, CAUSING BRUISING ON THE LEFT UPPER SHOULDER AND SKIN TEARS TO THE LEFT FOREARM AND RIGHT LOWER LEG. THE CNA IMMEDIATELY CALLED FOR ASSISTANCE. HOSPITALIZATION WAS NOT REQUIRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TEMPO PPP | PATIENT LIFT | FSA | ARJO MED AB LTD. | KPBXXXX |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 79 YR | Other |