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