FDA Adverse Event
Malfunction
Summary report: N
NON AC-POWERED PATIENT LIFT
MDR report key: 2912057
·
Received January 11, 2013
Report
- Report Number
- 3004493922-2013-00081
- Event Type
- Malfunction
- Date Received
- January 11, 2013
- Report Date
- January 11, 2013
- Manufacturer
- INVACARE SUZHOU
- Product Code
- FSA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
(B)(4). NO RMA HAS BEEN INITIATED FOR THIS ISSUE. THE MALFUNCTION HAS NOT BEEN CONFIRMED.
Description of Event or Problem · 1
(B)(4). NO SERIOUS INJURY ALLEGED. MALFUNCTION ALLEGED. CONSUMER STATES UNIT ALLEGEDLY WON'T LOWER COMPLETELY AND IS SQUEAKING. MDR FILED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 18659 | NON AC-POWERED PATIENT LIFT | 880.5510 | FSA | INVACARE SUZHOU | RPS350-2 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |