FDA Adverse Event Injury Summary report: N

RISE ATLAS 450M

MDR report key: 3606738 · Received January 21, 2014

Report

Report Number
3005536958-2014-00001
Event Type
Injury
Date Received
January 21, 2014
Date of Event
December 23, 2013
Report Date
January 21, 2014
Manufacturer
HANDICARE AB
Product Code
FSA
Adverse Event
Yes
Report Source
Distributor report
Reporter Location
TX, US
Reporter Occupation
OTHER

Narratives

Description of Event or Problem · 1

DURING A PT TRANSFER USING A CEILING HOIST, THE OPERATOR PULLED THE RED EMERGENCY LOWERING CORD WHICH RESULTED IN LIFTING THE PT UP. THE OPERATOR PULLED THE CORD A SECOND TIME WHICH RESULTED IN THE ENTIRE STRAP BEING PULLED ALL THE WAY INTO THE LIFT MOTOR CASING. THE OPERATOR PUSHED THE DOWN BUTTON ON THE HAND CONTROLLER AND NOTHING HAPPENED. IN ORDER TO LOWER THE PT, THE CARE GIVER CUT THE STRAPS OF THE SLING AND LOWERED THE PT, HALF INTO A RECLINER AND HALF ONTO THE FLOOR. AN AMBULANCE WAS CALLED WHICH TOOK THE PT TO THE HOSPITAL FOR OBSERVATION. THE CEILING HOIST WAS TAKEN OUT OF SVC AND RETURNED TO HANDICARE FOR ANALYSIS. OUR ANALYSIS SHOWED THAT THE LIFT STRAP HAD BEEN WRAPPED AROUND THE SPOOL IN OPPOSITE DIRECTION TO NORMAL RUNNING. THIS OCCURS WHEN THE EMERGENCY LOWERING CORD IS PULLED UNTIL THE ENTIRE 6 FT LIFTING STRAP IS PAID OUT. WHEN CONTINUING TO PULL THE EMERGENCY LOWERING STRAP, THE SPOOL CONTINUES TO TURN WHICH CAUSES THE LIFTING STRAP TO REWRAP IN THE OPPOSITE DIRECTION. WHEN THIS OCCURS, IF THE EMERGENCY LOWERING STRAP IS CONTINUOUSLY PULLED, THE LIFTING STRAP WILL CONTINUE TO BE PULLED INTO THE LIFT UNTIL IT IS FULLY WOUND INTO THE LIFT MOTOR CASING. WE HAVE THEREFORE CONCLUDED THAT SOMEONE HAD, PRIOR TO THE TRANSFER, PULLED THE EMERGENCY CORD CAUSING THE STRAP TO WRAP AROUND THE SPOOL IN THE OPPOSITE DIRECTION. THE EMERGENCY LOWERING MECHANISM IS DESIGNED TO SAFELY LOWER A PT IN THE EVENT OF A BREAKDOWN AND SHOULD NOT BE USED IN THIS MANNER WHEN ATTEMPTING TO TRANSFER A PT AS STATED IN THE OPERATING MANUAL.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
49686 RISE ATLAS 450M FSA HANDICARE AB 450M

Patients

Seq Age Sex Outcome Treatment
1 Hospitalization