FDA Adverse Event Death Summary report: N

SABINA II

MDR report key: 669548 · Received January 20, 2006

Report

Report Number
1225750-2005-00024
Event Type
Death
Date Received
January 20, 2006
Date of Event
December 23, 2005
Report Date
January 20, 2006
Manufacturer
LIKO AB
Product Code
FSA
Adverse Event
Yes
Report Source
Distributor report
Reporter Location
TN, US
Reporter Occupation
OTHER

Narratives

Description of Event or Problem · 1

IN 2005 WHILE USING A SABINA II PT LIFT WITH SAFETY SLING, A PT EXPIRED DURING TRANSFER. ACCORDING TO THE FACILITY, THE SUPPORT VEST USED (MED) DID NOT HAVE THE INTERLOCKING SNAP BUCKLE ON THE FRONT ANYMORE. THE STAFF PLACED THE SLING ON THE RESIDENT WITHOUT USING THE INTERLOCKING SNAP BUCKLE. THE RESIDENT GOT COMPLETELY FAINT DURING THE TRANSFER. THE STAFF TRIED TO EASE HER TO THE FLOOR. THE STAFF WERE IN AGREEMENT THAT THE RESIDENT WAS DYING IN THE LIFT. PT EXPIRED SOON AFTER BEING PLACED ON THE FLOOR. FOUR DAYS LATER THE LIFT WAS INSPECTED BY LIKO DISTRIBUTOR AND FOUND TO BE IN PROPER WORKING ORDER. IT IS THE OPINION OF LIKO INC THAT THE PT DEATH WAS NOT CAUSED BY ANY FAILURE OF THE LIFT OR SLING ATTACHMENT USED IN THE TRANSFER.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 SABINA II PT LIFT/HOIST FSA LIKO AB SABINA II *

Patients

Seq Age Sex Outcome Treatment
1 NA Death