FDA Adverse Event Injury Summary report: N

ROMEDIC EVA400EE

MDR report key: 3159150 · Received June 3, 2013

Report

Report Number
3005536958-2013-00034
Event Type
Injury
Date Received
June 3, 2013
Date of Event
February 1, 2013
Report Date
June 3, 2013
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

TWO EMPLOYEES WERE TRANSFERRING A MALE RESIDENT FROM A CHAIR TO A BED USING A PT LIFT DEVICE. WHEN THE RESIDENT WAS POSITIONED OVER THE BED, EMPLOYEE 1 STARTED LOWERING THE RESIDENT, THE LIFT TILTED FORWARD CAUSING EMPLOYEE 2 TO FALL BACKWARDS ONTO THE FLOOR WHILE TRYING TO ENSURE THE RESIDENT DID NOT FALL OFF THE BED. EMPLOYEE 2 SUSTAINED A STRAIN TO HER LOWER BACK AND GROIN. THE LIFT WAS REMOVED FROM THE FLOOR AND TAKEN TO THE FACILITIES MAINTENANCE FOR INSPECTION. THE FACILITIES MAINTENANCE INSPECTED THE UNIT. THE LIFT HAD NO APPARENT DAMAGE BUT IT WAS NOTED THAT THE THREADS ON THE SCREW ATTACHING THE LEG SPREAD MECHANISM WERE STRIPPED AND THE SCREW WAS LOOSE. THE FACILITIES MAINTENANCE ORDERED AND REPLACED THE SCREW. THE LIFT WAS RETURNED TO THE FLOOR.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
242933 ROMEDIC EVA400EE FSA HANDICARE AB EVA400EE

Patients

Seq Age Sex Outcome Treatment
1