FDA Adverse Event
Injury
Summary report: N
NON AC-POWERED PATIENT LIFT
MDR report key: 3230700
·
Received July 16, 2013
Report
- Report Number
- 3004493922-2013-01518
- Event Type
- Injury
- Date Received
- July 16, 2013
- Date of Event
- June 25, 2013
- Report Date
- June 26, 2013
- Manufacturer
- INVACARE SUZHOU
- Product Code
- FSA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). MALFUNCTION ALLEGED. THE PROVIDER STATED A RESIDENT ALLEGEDLY FELL TO THE GROUND AS THE SWIVEL ARM ON THE INVACARE LIFT CAME APART AND BROKE. THE RESIDENT ALLEGEDLY HAS A LEFT HIP CONTUSION BUT WAS NOT HOSPITALIZED. MEDICAL INTERVENTION PROVIDED BY FACILITY. THE LIFT WAS TAKEN OUT OF SERVICE.
Description of Event or Problem · 1
THE PROVIDER STATED A RESIDENT ALLEGEDLY FELL TO THE GROUND AS THE SWIVEL ARM ON THE INVACARE LIFT CAME APART AND BROKE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 329215 | NON AC-POWERED PATIENT LIFT | 880.5510 | FSA | INVACARE SUZHOU | RPL450-2 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |