FDA Adverse Event
Malfunction
Summary report: N
UNO
MDR report key: 1946053
·
Received December 17, 2010
Report
- Report Number
- 8030916-2010-00041
- Event Type
- Malfunction
- Date Received
- December 17, 2010
- Date of Event
- July 13, 2009
- Report Date
- July 13, 2009
- Manufacturer
- LIKO AB
- Product Code
- FSA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OK, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THIS MDR IS PART OF A RETROSPECTIVE REVIEW IN ACCORDANCE WITH CAPA ACTIVITIES.
Description of Event or Problem · 1
FACILITY STAFF WERE IN THE PROCESS OF MOVING A PT FROM A WHEELCHAIR TO HER BED USING AN UNO 102. WITH THE PT UP IN THE AIR, THE LIFT WOULD NOT OPERATE IN THE DOWN POSITION. THEY TRIED TURNING THE EMERGENCY RELEASE AND AT A CERTAIN POINT THEY COULD NO LONGER TURN THE RELEASE DOWN. SIX OF THE HOSP STAFF WERE ABLE TO REMOVE PT FROM LIFT AND PLACE ONTO HER BED. NO ONE WAS HURT OR INJURED BY THIS INCIDENT AND NO PT INFO WAS PROVIDED WHEN REQUESTED. THE LIFT IS NOW OUT OF SERVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNO | NON-AC POWERED PATIENT LIFT | FSA | LIKO AB | UNO 102EE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |