FDA Adverse Event
Death
Summary report: N
PAL VOLARO
MDR report key: 622757
·
Received July 22, 2005
Report
- Report Number
- 2132280-2005-00006
- Event Type
- Death
- Date Received
- July 22, 2005
- Date of Event
- July 8, 2005
- Report Date
- July 12, 2005
- Manufacturer
- SUNRISE MACHINE AND TOOL, INC.
- Product Code
- FSA
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
RESIDENT WAS BEING LIFTED USING A VOLARO LIFT. THE LEFT SIDE SLING ATTACHMENT CAME OUT OF HOOK CLIP AND THE RESIDENT FELL TO THE FLOOR. THE LEFT SIDE OF RESIDENT'S HEAD HIT THE FLOOR. THE RESIDENT WAS SENT TO THE HOSPITAL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PAL VOLARO | FULL BODY LIFT | FSA | SUNRISE MACHINE AND TOOL, INC. | PC45054 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 84 YR | Death |