FDA Adverse Event
Malfunction
Summary report: N
OPERA PPP
MDR report key: 397569
·
Received May 31, 2002
Report
- Report Number
- 9617021-2002-00092
- Event Type
- Malfunction
- Date Received
- May 31, 2002
- Date of Event
- March 1, 2002
- Report Date
- April 30, 2002
- Manufacturer
- ARJO, LTD.
- Product Code
- FSA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- UNKNOWN
Narratives
Description of Event or Problem · 1
THE FACILITY REPORTS THE PATIENT WAS BEING TRANSFERRED TO WHEELCHAIR. ONCE IN POSITION CARERS ATTEMPTED TO RAISE THE LIFT BUT IT WOULD NOT MOVE. THE O.T. AND R.N. MOVED THE WHEELCHAIR FROM UNDER THE TRANSFER BAR WITH.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | OPERA PPP | PATIENT LIFT | FSA | ARJO, LTD. | KPBXXXX | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN |