FDA Adverse Event
Other
Summary report: N
UNO
MDR report key: 962356
·
Received May 2, 2007
Report
- Report Number
- 1225750-2007-00009
- Event Type
- Other
- Date Received
- May 2, 2007
- Date of Event
- March 26, 2007
- Report Date
- April 17, 2007
- Manufacturer
- LIKO INC
- Product Code
- FSA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
IN 2007, A LIKO DISTRIBUTOR WAS ALLOWED TO VIEW AND EXAMINE THE UNO PT LIFT. THE ACTUATOR WAS REPLACED AND THE LIFT RETURNED TO SERVICE AT THE FACILITY. WHILE INSPECTING THE LIFT THE DISTRIBUTOR NOTED THE FOLLOWING: "THE FRONT CASTORS WERE LOOSE AND BENDING AT AN ANGLE. CHARGING CABLE WAS PATCHED WITH ELETRICIANS TAPE AND A NEW PLUG AND BEEN ADDED. BASE ACTUATOR HELD IN PLACE WITH A NON-SPEC SCREW. ALL WHEELS NEEDED CLEANING." THE BENT ACTUATOR WILL BE RETURNED TO THE MFR FOR ANALYSIS.
Description of Event or Problem · 1
FACILITY REPORTS THAT WHILE LOWERING A 320LB RESIDENT INTO BED, USING AN UNO 102 PT LIFT THAT THE ACTUATOR BENT. RESIDENT DID NOT SUFFER ANY INJURY AS HE WAS ALREADY CLOSE TO THE BED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNO | * | FSA | LIKO INC | UNO 102 | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 55 YR | Other |