FDA Adverse Event
Other
Summary report: N
VANDERLIFT 450
MDR report key: 1062391
·
Received June 16, 2008
Report
- Report Number
- 1933441-2008-00003
- Event Type
- Other
- Date Received
- June 16, 2008
- Date of Event
- May 30, 2008
- Report Date
- June 16, 2008
- Manufacturer
- VANCARE, INC.
- Product Code
- FSA
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
DISTRIBUTOR DID IN-SERVICE TRAINING ON 6-12-08. VANDERLIFT WAS CHECKED OVER WHEN IN-SERVICE TRAINING WAS COMPLETED. (B) (4) STATED THAT SHE FELT THAT THE LIFT WAS NOT THE PROBLEM, BUT RATHER USER ERROR CONTRIBUTED TO EVENT.
Description of Event or Problem · 1
DISTRIBUTOR WAS NOTIFIED TWO WEEKS AFTER ACCIDENT HAPPENED. CNA WAS TRANSFERRING RESIDENT FROM HER BED TO A CHAIR, THE RESIDENT STARTED TO LEAN OUT OF SLING WITH HER UPPER BODY. CNA GRABBED RESIDENT AND PULLED HER BACK INTO THE SLING WHILE LOWERING THE LIFT. RESIDENT HAS A HISTORY OF POOR UPPER BODY CONTROL (SIDE TO SIDE). THE RESIDENT RECEIVED A BRUISE FROM THE COLLAR THAT THE EMT PLACED ON HER, THIS IS THE ONLY INJURY REPORTED. THE PT LIFT WAS NOT THE CAUSE OF THIS ACCIDENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VANDERLIFT 450 | VANDERLIFT 450 | FSA | VANCARE, INC. | 450 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization |