BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AC-POWERED PATIENT LIFT

    MDR report key: 2185076 · Received August 1, 2011

    Report

    Report Number
    1525712-2011-00401
    Event Type
    Malfunction
    Date Received
    August 1, 2011
    Date of Event
    July 6, 2011
    Report Date
    July 29, 2011
    Manufacturer
    INVACARE
    Product Code
    FNG
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ONLY ONE ASSISTANT WAS TRANSFERRING THE CONSUMER. OWNERS MANUAL PART NO (B)(4) PAGE 13 STATES "ALTHOUGH INVACARE RECOMMENDS THAT TWO ASSISTANTS BE USED FOR ALL LIFTING PREPARATION, TRANSFERRING FROM AND TRANSFERRING TO PROCEDURES, OUR EQUIPMENT WILL PERMIT PROPER OPERATION BY ONE ASSISTANT. THE USE OF ONE ASSISTANT IS BASED ON THE EVALUATION OF THE HEALTHCARE PROFESSIONAL FOR EACH INDIVIDUAL CASE. " IT IS UNKNOWN IF THE ASSISTANT FOLLOWED THE FOLLOWING GUIDANCE. OWNERS MANUAL (B)(4) PAGE 15 STATED "DURING TRANSFER, WITH PATIENT SUSPENDED IN A SLING ATTACHED TO THE LIFT, DO NOT ROLL CASTER BASE OVER OBJECTS SUCH AS CARPET, RAISED CARPET BINDINGS, DOOR FRAMES, OR ANY UNEVEN SURFACES OR OBSTACLES THAT WOULD CREATE AN IMBALANCE OF THE PATIENT LIFT AND COULD CAUSE THE PATIENT LIFT TO TIP OVER. USE STEERING HANDLE ON THE MAST AT ALL TIMES TO PUSH OR PULL THE PATIENT LIFT. INVACARE DOES NOT RECOMMEND LOCKING OF THE REAR CASTERS OF THE PATIENT LIFT WHEN LIFTING AN INDIVIDUAL. DOING SO COULD CAUSE THE LIFT TO TIP AND ENDANGER THE PATIENT AND ASSISTANTS. INVACARE DOES RECOMMEND THAT THE REAR CASTERS BE LEFT UNLOCKED DURING LIFTING PROCEDURES TO ALLOW THE PATIENT LIFT TO STABILIZE ITSELF WHEN THE PATIENT IS INITIALLY LIFTED FROM A CHAIR, BED OR ANY STATIONARY OBJECT." IT IS UNKNOWN IIF THE ASSISTANT FOLLOWED THE FOLLOWING GUIDANCE FOR THE COMMODE CHAIR OR THE STANDARD COMMODE AS STATED IN THE OWNERS MANUAL. PAGE 30 "TRANSFERRING TO A COMMODE CHAIR". BEFORE LIFTING THE PATIENT FROM THE BED, REFER TO ATTACHING SLINGS TO THE LIFT ON PAGE 27. FOR OPERATION OF THE PATIENT LIFT, REFER TO OPERATION ON PAGE 20. THE PATIENT SHOULD BE ELEVATED HIGH ENOUGH TO CLEAR THE COMMODE CHAIR ARMS AND HAVE THEIR WEIGHT SUPPORTED BY THE PATIENT LIFT. WITH THE HELP OF BOTH ASSISTANTS, GUIDE THE PATIENT ONTO THE COMMODE CHAIR. LOWER THE PATIENT ONTO THE COMMODE CHAIR LEAVING THE SLING ATTACHED TO THE SWIVEL BAR HOOKS. WHEN COMPLETE, RECHECK FOR CORRECT ATTACHMENT AND THEN RAISE THE PATIENT OFF THE COMMODE CHAIR. WHEN PATIENT IS CLEAR OF THE COMMODE SURFACE (USING THE STEERING HANDLES), MOVE THE LIFT AWAY FROM THE COMMODE CHAIR. TO RETURN THE PATIENT TO BED, REVERSE THE PROCEDURES FOR LIFTING THE PATIENT, OPERATION AND SLING ATTACHMENT. TO RETURN OR PLACE THE PATIENT IN A WHEELCHAIR, REFER TO TRANSFERRING TO A WHEELCHAIR ON PAGE 32." PAGE 31 "TRANSFERRING A PATIENT TO A STANDARD COMMODE" BEFORE LIFTING THE PATIENT FROM THE BED, REFER TO ATTACHING SLINGS TO THE LIFT ON PAGE 27. FOR OPERATION OF THE PATIENT LIFT, REFER TO OPERATION ON PAGE 20. TRANSPORT THE PATIENT TO THE BATHROOM FACILITY. THE PATIENT SHOULD BE ELEVATED HIGH ENOUGH TO CLEAR THE STANDARD COMMODE AND HAVE THEIR WEIGHT SUPPORTED BY THE PATIENT LIFT. WITH THE HELP OF BOTH ASSISTANTS, GUIDE THE PATIENT ONTO THE STANDARD COMMODE. LOWER THE PATIENT ONTO THE STANDARD COMMODE LEAVING THE SLING ATTACHED TO THE SWIVEL BAR HOOKS. WHEN COMPLETE, RECHECK FOR CORRECT ATTACHMENT AND THEN RAISE THE PATIENT OFF THE STANDARD COMMODE. WHEN PATIENT IS CLEAR OF THE STANDARD COMMODE SURFACE (USING THE STEERING HANDLE), MOVE THE LIFT AWAY FROM THE STANDARD COMMODE. TO RETURN OR PLACE PATIENT IN A WHEELCHAIR, REFER TO TRANSFERRING TO A WHEELCHAIR ON PAGE 32. TO RETURN THE PATIENT TO BED, REVERSE THE PROCEDURES FOR LIFTING THE PATIENT, OPERATION AND SLING ATTACHMENT." RMA 859411448 HAS BEEN GENERATED FOR THE RETURN OF THE LIFT.

    Description of Event or Problem · 1

    THE CONSUMER WAS BEING LIFTED FROM A COMMODE TO THE BED BY A NURSE. AS THE LIFT BEGAN TO LOWER THE CONSUMER DOWN, THE BOOM ALLEGEDLY BEGAN TO SWAY AND FELL TO THE RIGHT, CAUSING THE CONSUMER TO FALL TO THE BED AND PINCH HER ARM BETWEEN THE BED AND LIFT. NO SERIOUS INJURY IS ALLEGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AC-POWERED PATIENT LIFT 880.5500 FNG INVACARE RPL450-1

    Patients

    Seq Age Sex Outcome Treatment
    1