FDA Adverse Event
Malfunction
Summary report: N
PREMIER CTS 48272
MDR report key: 3973011
·
Received July 29, 2014
Report
- Report Number
- MW5037539
- Event Type
- Malfunction
- Date Received
- July 29, 2014
- Date of Event
- July 8, 2014
- Report Date
- July 28, 2014
- Manufacturer
- SUNRISE MEDICAL
- Product Code
- FSA
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Description of Event or Problem · 1
LIFT WOULD NOT LIFT WHEN PUMPED UP, KEPT SLOWLY DESCENDING. PATIENT FELL FROM HOYER LIFT, WHILE NURSES ATTEMPTED TO GET HER OUT OF BED, RECEIVING A SKIN TEAR TO RLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 441661 | PREMIER CTS 48272 | HOYER LIFT | FSA | SUNRISE MEDICAL | HML400 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 84 YR |