FDA Adverse Event
Malfunction
Summary report: N
SABINA
MDR report key: 2243511
·
Received August 19, 2011
Report
- Report Number
- 8030916-2011-00057
- Event Type
- Malfunction
- Date Received
- August 19, 2011
- Date of Event
- July 27, 2011
- Report Date
- July 27, 2011
- Manufacturer
- LIKO AB
- Product Code
- FSA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
REPLACEMENT MAST WAS SENT TO THE FACILITY. FACILITY CONFIRMED THE LIFT IS NOW WORKING AS DESIGNED AND BACK IN OPERATION.
Description of Event or Problem · 1
FACILITY STAFF CALLED TO SAY THEY HAVE A SABINA II EE LIFT THAT THEY FEEL HAS A BROKEN WELD ON THE MAST/ARM. NO INJURY ALLEGED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SABINA | NON-AC POWERED PATIENT LIFT | FSA | LIKO AB | SABINA II EE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |