FDA Adverse Event
Malfunction
Summary report: N
HOYER
MDR report key: 3820302
·
Received May 15, 2014
Report
- Report Number
- MW5036133
- Event Type
- Malfunction
- Date Received
- May 15, 2014
- Date of Event
- May 2, 2014
- Report Date
- May 13, 2014
- Manufacturer
- SUNRISE MEDICAL
- Product Code
- FSA
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Description of Event or Problem · 1
PT WAS BEING LIFTED OUT OF BED WITH HOYER LIFT WHEN BOLT ATTACHING SPREADER BAR TO LIFT SNAPPED OFF AND PT FELL BACK TO BED. NO INJURY TO PT. LIFT WAS INSPECTED BY BIOMED 1-2014.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 291485 | HOYER | MECHANICAL LIFT | FSA | SUNRISE MEDICAL |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 80 YR |