FDA Adverse Event
Malfunction
Summary report: N
NON AC-POWERED PATIENT LIFT
MDR report key: 2832847
·
Received November 14, 2012
Report
- Report Number
- 1525712-2012-02173
- Event Type
- Malfunction
- Date Received
- November 14, 2012
- Date of Event
- October 18, 2012
- Report Date
- November 12, 2012
- Manufacturer
- INVACARE TAYLOR STREET
- Product Code
- FSA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
(B)(4)- RMA HAS BEEN INITIATED FOR THIS ISSUE. MODEL RHA450-1, SERIAL NUMBER/DATE CODE (B)(4) IS APPROXIMATELY EIGHT YEAR OLD. THE CONSUMER'S AGE, HEIGHT AND WEIGHT ARE UNKNOWN. THE CONSUMER'S MEDICAL CONDITION, STABILITY AND MEDICATION REGIMEN ARE UNKNOWN. THE CONSUMER'S TECHNIQUE WHILE USING THE DEVICE AND THE MAINTENANCE HISTORY OF THE DEVICE ARE UNKNOWN. THE MALFUNCTION HAS NOT BEEN CONFIRMED.
Description of Event or Problem · 1
(B)(4) - THE DEALER REPORTED THAT THE RHA450-1 HYDRAULIC LIFT PUMP WAS FUNCTIONING INTERMITTENTLY, AND IT WOULD TAKE A WHILE TO START RISING AFTER COMMAND. THERE WAS NO INJURY REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NON AC-POWERED PATIENT LIFT | 880.5510 | FSA | INVACARE TAYLOR STREET | RHA450-1 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |