FDA Adverse Event
Other
Summary report: N
HOYER LIFTER
MDR report key: 1221819
·
Received November 3, 2008
Report
- Report Number
- 2182305-2008-00036
- Event Type
- Other
- Date Received
- November 3, 2008
- Date of Event
- August 6, 2008
- Report Date
- September 5, 2008
- Manufacturer
- JOERNS HEALTHCARE, INC.
- Product Code
- FSA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE IS 20+ YEARS OLD, HAS EXCEEDED EXPECTED LIFE OF PRODUCT SHOULD BE TAKEN OUT OF SERVICE.
Description of Event or Problem · 1
IT WAS REPORTED TO MANUFACTURER, BY FACILITY, PER FACILITY PATIENT WAS PLACED ON LIFT SLING WHILE ON HER BED, PATIENT WAS LIFTED UP AND OUT OF THE BED, THEN WITH MOVEMENT OF THE LIFT, THE LIFT BROKE AND PATIENT FELL TO THE FLOOR. PATIENT WAS TAKEN TO ER FOR X-RAYS. PER MANUFACTURER, DEVICE HAS EXCEEDED EXPECTED LIFE OF PRODUCT; FACILITY STATES LIFT IS 20+ YEARS. RECORD DO NOT GO BACK THAT FAR, CAN NOT CONFIRM MFG OR SHIP DATE. MFG ADVISED FACILITY TO TAKE OUT OF SERVICE, PER FACILITY DEVICE IS AVAILABLE FOR EVALUATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HOYER LIFTER | PATIENT LIFTER | FSA | JOERNS HEALTHCARE, INC. | C-HLA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 76 YR | Hospitalization |