FDA Adverse Event Death Summary report: N

VANDERLIFT 450

MDR report key: 2012291 · Received February 25, 2011

Report

Report Number
1933441-2011-00001
Event Type
Death
Date Received
February 25, 2011
Date of Event
January 21, 2011
Report Date
February 28, 2011
Manufacturer
VANCARE, INC.
Product Code
FSA
Report Source
Manufacturer report
Reporter Location
MI, US
Reporter Occupation
OTHER

Narratives

Additional Manufacturer Narrative · 1

DISTRIBUTOR REPORT INCLUDED IN THIS REPORT. EVALUATION OF LIFT DONE AT FACILITY AND NOTES ATTACHED WITH FINDINGS AT THAT TIME. VANDERLIFT DID NOT HAVE A MECHANICAL MALFUNCTION. FACILITY REFUSED TO LET DISTRIBUTOR TAKE PICTURES OF SAID LIFT IN QUESTION AND SLING.

Description of Event or Problem · 1

CNA ATTACHED INVACARE SLING TO VANDERLIFT AND RESIDENT FELL OUT THE FRONT OF INVACARE SLING AND FELL AND LANDED ON HEAD. ADMINISTRATOR STATED, IT WAS NOT A MECHANICAL MALFUNCTION, AND NOT A SLING MALFUNCTION. TWO CNA'S DID THE TRANSFER OF THIS RESIDENT. AS STATED IN THE VANCARE MANUAL, YOU ARE TO USE ONLY VANCARE SLINGS ON VANDERLIFTS.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 VANDERLIFT 450 VANDERLIFT 450 PATIENT LIFT FSA VANCARE, INC. 450

Patients

Seq Age Sex Outcome Treatment
1 NA Death