FDA Adverse Event
Injury
Summary report: N
TRANSLIFT SLING LIFT
MDR report key: 494899
·
Received November 10, 2003
Report
- Report Number
- 1045510-2003-00027
- Event Type
- Injury
- Date Received
- November 10, 2003
- Date of Event
- October 9, 2003
- Report Date
- November 7, 2003
- Manufacturer
- HILL-ROM MANUFACTURING, INC.
- Product Code
- FSA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- INVALID DATA
Narratives
Description of Event or Problem · 1
CAREGIVER ALLEGED THAT THEY HURT THEIR BACK (LUMBAR STRAIN) WHEN THE PATIENT LIFT STARTED TO TIP, AND THEY GRABBED THE PATIENT. THE LEGS OF THE LIFT SPREAD TO PREVENT TIPPING, BUT WERE NOT SPREAD (CONTRARY TO INSTRUCTIONS FOR USE) AT THE TIME OF INJURY. MANUFACTURER'S EXAMINATION OF DEVICE INDICATED LEG SPREADING MECHANISM HAD BEEN SUBJECTED TO MODIFICATION BY CONSIGNEE. A TIE ROD HAD BEEN REMOVED, MAKING THE LEG SPREADING MECHANISM INOPERABLE. CONSIGNEE DECLINED REPAIR BY MANUFACTURER, BUT ACCEPTED MISSING TIE ROD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TRANSLIFT SLING LIFT | PATIENT LIFT, NON-AC POWERED | FSA | HILL-ROM MANUFACTURING, INC. | P443 | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * | Required Intervention |