FDA Adverse Event
Malfunction
Summary report: N
NON AC-POWERED PATIENT LIFT
MDR report key: 2893858
·
Received January 2, 2013
Report
- Report Number
- 3007231105-2013-00001
- Event Type
- Malfunction
- Date Received
- January 2, 2013
- Report Date
- January 2, 2013
- Manufacturer
- AQUATEC OPERATIONS GMBH
- Product Code
- FSA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Description of Event or Problem · 1
A REPORT HAS BEEN RECEIVED FROM (B)(6) OF A FAULTY HAND CONTROL. THE BATH LIFT IS FOR AN END USER WHO HAS HAD THE LIFT IN HIS HOME SINCE (B)(6) 2011. THE END USER WAS IN THE LIFT WHEN THE HAND CONTROL WENT OUT. THE LIFT WOULD GO UP BUT NOT COME DOWN. HE STATES THE END USER HAS TO BE TRANSFERRED OUT OF THE LIFT BECAUSE IT WAS STUCK IN THE UP POSITION. A LONER LIFT WAS ISSUED WHILE THE HAND CONTROL WAS WORKED ON. NO INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 836 | NON AC-POWERED PATIENT LIFT | 880.5510 | FSA | AQUATEC OPERATIONS GMBH | 1471565 LIFT |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |