FDA Adverse Event
Malfunction
Summary report: N
NON AC-POWERED PATIENT LIFT
MDR report key: 2873051
·
Received December 13, 2012
Report
- Report Number
- 3004493922-2012-00688
- Event Type
- Malfunction
- Date Received
- December 13, 2012
- Report Date
- December 13, 2012
- Manufacturer
- INVACARE SUZHOU
- Product Code
- FSA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
(B)(4) 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. DEALER STATES THAT THE PATIENT TRANSPORT KNOB ON THE LOCKING ELEMENT CAN COMPLETELY BE PULLED OUT OF THE HYDRAULIC PUMP AND FLUID IS LEAKING OUT. MDR FILED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NON AC-POWERED PATIENT LIFT | 880.5510 | FSA | INVACARE SUZHOU | 9805P |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |