FDA Adverse Event
Malfunction
Summary report: N
NON AC-POWERED PATIENT LIFT
MDR report key: 2921390
·
Received January 17, 2013
Report
- Report Number
- 1525712-2013-00457
- Event Type
- Malfunction
- Date Received
- January 17, 2013
- Report Date
- January 17, 2013
- Manufacturer
- UNKNOWN
- Product Code
- FSA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIST
Narratives
Additional Manufacturer Narrative · 1
MDR DECISION DATE: (B)(4) HAS BEEN INITIATED FOR THIS ISSUE. THE MALFUNCTION HAS NOT BEEN CONFIRMED.
Description of Event or Problem · 1
MDR DECISION DATE: (B)(6). NO SERIOUS INJURY ALLEGED. MALFUNCTION ALLEGED. DEALER STATES PUMP HAS LEAKED ALL ITS OIL. MDR FILED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 25832 | NON AC-POWERED PATIENT LIFT | 880.5510 | FSA | UNKNOWN | 9805 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |