FDA Adverse Event
Injury
Summary report: N
INVACARE RELIANT 450
MDR report key: 1172825
·
Received July 25, 2008
Report
- Report Number
- 1172825
- Event Type
- Injury
- Date Received
- July 25, 2008
- Date of Event
- July 11, 2008
- Report Date
- July 24, 2008
- Manufacturer
- INVACARE LINAK U.S. INC.
- Product Code
- FSA
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- KS, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
AN INVACARE RELIANT 450 FULL BODY SLING LIFT WAS BEING USED TO TRANSFER A NON-WEIGHT BEARING PT FROM THE BED TO CHAIR. THE BOLT THAT ATTACHES THE SLING HARDWARE TO THE MECHANICAL LIFT ARM HAD WORKED ITS WAY OUT, AND THE PT AND SLING ASSEMBLY DETACHED, AND BOTH FELL TO THE FLOOR. THE NUT THAT ATTACHED THE SLING ASSEMBLY HAD FALLEN OFF. NO COTTER KEY ON SAFETY WIRE TO KEEP IT SECURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INVACARE RELIANT 450 | FULL BODY PATIENT LIFT | FSA | INVACARE LINAK U.S. INC. | RPL-450-1 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 78 YR | Hospitalization| L| O |