FDA Adverse Event
Malfunction
Summary report: N
NON AC-POWERED PATIENT LIFT
MDR report key: 4112722
·
Received September 24, 2014
Report
- Report Number
- 3008262382-2014-01240
- Event Type
- Malfunction
- Date Received
- September 24, 2014
- Date of Event
- September 2, 2014
- Report Date
- September 3, 2014
- Manufacturer
- INVACARE REHABILITATION EQUIP
- Product Code
- FSA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Description of Event or Problem · 1
END USER STATED THE POLE THAT IS USED TO RAISE AND LOWER HAS CRACKED IN HALF. SHE STATED NO INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 595531 | NON AC-POWERED PATIENT LIFT | 880.5510 | FSA | INVACARE REHABILITATION EQUIP | RPS350-2 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 34 | Other |