FDA Adverse Event
Injury
Summary report: N
NON AC-POWERED PATIENT LIFT
MDR report key: 2041936
·
Received March 29, 2011
Report
- Report Number
- 1525712-2011-00139
- Event Type
- Injury
- Date Received
- March 29, 2011
- Date of Event
- February 22, 2011
- Report Date
- March 29, 2011
- Manufacturer
- INVACARE
- Product Code
- FSA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CONSUMER WAS BEING TRANSFERRED BY A VISITING NURSES AIDE, AND THE LIFT ALLEGEDLY TIPPED WITH THE CONSUMER IN THE SLING. THE AGE OF THE LIFT IS UNK THE SERIAL NUMBER PROVIDED IS NOT COMPLETE. DEVICE SERVICE AND MAINTENANCE HISTORY IS UNK. NATURE OF THE COMPLAINT SUGGESTS A TRANSFER ERROR. USER GUIDES ARE CLEAR IN INSTRUCTING AS TO THE PROPER AND SAFE USE OF THE PRODUCT. MALFUNCTION IS NOT CONFIRMED.
Description of Event or Problem · 1
THE LIFT ALLEGEDLY TIPPED OVER WITH THE CONSUMER IN THE SLING. NO SERIOUS INJURY IS ALLEGED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NON AC-POWERED PATIENT LIFT | 880.5510 | FSA | INVACARE | 9805 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 58 YR | Required Intervention |