FDA Adverse Event
Malfunction
Summary report: N
HOYER LIFT
MDR report key: 823435
·
Received January 31, 2007
Report
- Report Number
- 2182305-2006-00046
- Event Type
- Malfunction
- Date Received
- January 31, 2007
- Date of Event
- July 10, 2006
- Report Date
- December 22, 2006
- Manufacturer
- IMS, INC. INTEGRATED MEASUREMENT SYSTEM
- Product Code
- FSA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NE, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED TO MANUFACTURER, BY FACILITY, CARE CENTER, PER FACILITY THE 1/2 EYEBOLT THAT GOES FROM THE SCALE TO WHERE THE MAIN PIN GOES THROUGH HAS SNAPPED IN HALF. PATIENT WAS IN LIFT AT THE TIME. NO REPORTABLE INJURY PER FACILITY. THIS DEVICE HAS BEEN ISSUED TO HAVE PRODUCT RETURNED FOR EVALUATION. IN ADDITION, THE MANUFACTURER OF SCALE HAS BEEN NOTIFIED. THIS IS BEING REPORTED UNDER MALFUNCTION, WHICH COULD HAVE RESULTED IN SERIOUS INJURY OR DEATH AS DEFINED IN 21 CFR PART 803.3 / 803.5.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HOYER LIFT | PATIENT LIFTER | FSA | IMS, INC. INTEGRATED MEASUREMENT SYSTEM | PRESENCE W/ SCALE | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | YR | Other |