FDA Adverse Event
Summary report: N
NON AC-POWERED PATIENT LIFT
MDR report key: 2843244
·
Received November 21, 2012
Report
- Report Number
- 1531186-2012-01438
- Date Received
- November 21, 2012
- Date of Event
- October 23, 2012
- Report Date
- November 21, 2012
- Manufacturer
- LAND AMERICA HEALTH & FITNESS
- Product Code
- FSA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Description of Event or Problem · 1
MDR DECISION DATE: (B)(6) 2012. NO SERIOUS INJURY ALLEGED. MALFUNCTION ALLEGED. DEALER STATES THAT THE SCREWS BY THE HYDRAULIC PUMP HANDLE HAVE SNAPPED OFF. MDR FILED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NON AC-POWERED PATIENT LIFT | 880.5510 | FSA | LAND AMERICA HEALTH & FITNESS | GHS350 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 45 | Other |