FDA Adverse Event
Malfunction
Summary report: N
NON AC-POWERED PATIENT LIFT
MDR report key: 3256891
·
Received July 31, 2013
Report
- Report Number
- 3004493922-2013-01678
- Event Type
- Malfunction
- Date Received
- July 31, 2013
- Report Date
- July 16, 2013
- Manufacturer
- INVACARE SUZHOU
- Product Code
- FSA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
(B)(4) - FOLLOW UP #001. INITIAL (B)(4) ISSUED MFR. REPORT # 3004493922-2013-01678, INDICTING THE BRAND NAME AS AC POWERED LIFT WITH A COMMON DEVICE NAME OF 880.5500. THE CORRECT BRAND NAME IS NON-AC POWERED PATIENT LIFT WITH A COMMON DEVICE NAME OF 880.5510.
Description of Event or Problem · 1
IT WAS REPORTED THE RIGHT BRAKE ON THE RPS350-1 POWERED LIFT IS BROKEN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 357891 | NON AC-POWERED PATIENT LIFT | 880.5510 | FSA | INVACARE SUZHOU | RPS350-1 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |