FDA Adverse Event
Malfunction
Summary report: N
NON AC-POWERED PATIENT LIFT
MDR report key: 3300428
·
Received August 21, 2013
Report
- Report Number
- 9616091-2013-01592
- Event Type
- Malfunction
- Date Received
- August 21, 2013
- Report Date
- August 12, 2013
- Manufacturer
- INVAMEX
- Product Code
- FSA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Description of Event or Problem · 1
PROVIDER STATES THE LIFT MODEL GRPL450-1 NEEDED THESE PART REPLACED UNDER WARRANTY (B)(4), HANDLE MOUNT 1064122, SCREW 1029134, SCREW 1132033 CROSS SUPPORT DUE TO THEM BEING LOOSE AND STRIPPED SERIAL NUMBER OF LIFT IS (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 406215 | NON AC-POWERED PATIENT LIFT | 880.5510 | FSA | INVAMEX | GRPL450-1 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |