FDA Adverse Event
Other
Summary report: N
UNO 102
MDR report key: 844299
·
Received April 25, 2007
Report
- Report Number
- 1225750-2007-00008
- Event Type
- Other
- Date Received
- April 25, 2007
- Date of Event
- April 1, 2007
- Report Date
- April 10, 2007
- Manufacturer
- LIKO, INC.
- Product Code
- FSA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
FACILITY REPORTED THE INCIDENT TO LIKO INC. ON 04/10/2007. HOWEVER, ON 04/05/2007 THE FACILITY HAD ALLOWED AN UNAUTHORIZED TECHNICIAN TO REMOVE THE LIFT FROM THE FACILITY, EXAMINE IT AND REPAIR THE LIFT. WHEN AN AUTHORIZED LIKO DISTRIBUTOR WENT ON SITE 04/13/2007 THE LIFT WAS BACK IN SERVICE AND IN GOOD WORKING CONDITION.
Description of Event or Problem · 1
TWO AIDS TRANSFERRING RESIDENT FROM BED TO CHAIR USING AN UNO 102 PATIENT LIFT, LIFTED THE RESIDENT ABOVE THE BED AND TO A CHAIR. AS LOWERING BEGAN, THE LIFT AND RESIDENT TOPPLED TO THE RIGHT, RESIDENT FELL TO THE FLOOR. THE SAME LIFT WAS THEN USED TO TRANSFER THE RESIDENT FROM THE FLOOR AND BACK TO BED. FRACTURES TO BOTH OF THE RESIDENT'S LEGS WAS NOT NOTICED BY FACILITY UNTIL AFTER SUPPER THAT EVENING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNO 102 | * | FSA | LIKO, INC. | UNO 102 | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 40 YR | Other |