BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AC-POWERED PATIENT LIFT

    MDR report key: 2253255 · Received September 19, 2011

    Report

    Report Number
    1525712-2011-00527
    Event Type
    Malfunction
    Date Received
    September 19, 2011
    Date of Event
    October 14, 2010
    Report Date
    February 20, 2012
    Manufacturer
    UNKNOWN
    Product Code
    FNG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    NO RMA HAS BEEN ISSUED FOT THE RETURN OF THIS DEVICE. THE LIFT MODEL IS UNKNOWN. THE SERIAL NUMBER IS (B)(4) WHICH IS INCONSISTENT WITH AN INVACARE SERIAL NUMBER. THE MANUFACTURER OF THIS DEVICE IS UNKNOWN. IN THIS CASE THE PATIENT WAS NOT INJURED WHEN THE LIFT WHEEL CAME OFF. THE HEALTHCARE WORKER STRAINED HER ARM WHEN TRYING TO STEADY THE PATIENT. INVACARE PROVIDES THE FOLLOWING RECOMMENDATIONS FOR THEIR LIFTS IN ALL OF THEIR OWNERS MANUALS. FOR EXAMPLE MODEL RPL400 USER MANUAL PN 1145810 PAGE 13 STATES, "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 HEALTH CARE PROFESSIONAL FOR EACH INDIVIDUAL CASE." HAVING TWO ASSISTANTS MAY HAVE PREVENTED THE DEVICE FROM TILTING, LOOSING THE WHEEL AND THE CNA STRAINING HER ARM. ALSO, OTHER FACTORS THAT AFFECT TRANSFERRING PATIENTS ARE: MAINTENANCE OF THE DEVICE, AND THE LEGS MUST BE LOCKED IN THE MAXIMUM OPEN POSITION WHEN LIFTING. IT IS UNKNOWN IF THE FACILITY WAS FOLLOWING THE MAINTENANCE AND TRANSFERRING REQUIREMENTS FOR THEIR LIFT.

    Additional Manufacturer Narrative · 1

    (B)(4) ISSUED MFG REPORT #1525712-2011-00527. THE LIFT, MODEL 9805P, WAS RETURNED FOR INSPECTION. DISCREPANCY BETWEEN THE PRODUCT THAT WAS LISTED ON THE INCIDENT REPORT AND THAT OF THE PRODUCT RETURNED. THE INCIDENT REPORT LISTED A PRODUCT THAT WAS APPROXIMATELY 17 YEARS OLD AT THE TIME OF THE INCIDENT. THE PRODUCT RETURNED WAS APPROXIMATELY 6 MONTHS OLD, SERIAL NUMBER (B)(4). AFTER VIEWING THE LIFT, IT WAS CLEAR THAT THE RIGHT LEG WAS BENT UPWARD, CAUSING ONLY THREE WHEELS TO BE TOUCHING THE GROUND. THE BEND IS EVIDENCE THAT THE LIFT WAS BEING OVERLOADED ON THE RIGHT LEG. THIS MAY HAVE BEEN CAUSED FROM THE LIFT BEING DROPPED OR A LEG BEING TRAPPED. NO RMA HAS BEEN ISSUED FOR THE RETURN OF THIS DEVICE. THE LIFT MODEL IS UNKNOWN. THE SERIAL NUMBER IS (B)(4) WHICH IS INCONSISTENT WITH AN INVACARE SERIAL NUMBER. THE MANUFACTURER OF THIS DEVICE IS UNKNOWN. IN THIS CASE, THE PATIENT WAS NOT INJURED WHEN THE LIFT WHEEL CAME OFF. THE HEALTHCARE WORKER STRAINED HER ARM WHEN TRYING TO STEADY THE PATIENT. INVACARE PROVIDES THE FOLLOWING RECOMMENDATIONS FOR THEIR LIFTS IN ALL OF THEIR OWNERS MANUALS. FOR EXAMPLE, MODEL RPL400 USER MANUAL PN 1145810 PAGE 13 STATES, "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 HEALTH CARE PROFESSIONAL FOR EACH INDIVIDUAL CASE." HAVING TWO ASSISTANTS MAY HAVE PREVENTED THE DEVICE FROM TILTING, LOOSING THE WHEEL AND THE CNA STRAINING HER ARM. ALSO, OTHER FACTORS THAT AFFECT TRANSFERRING PATIENTS ARE: MAINTENANCE OF THE DEVICE, AND THE LEGS MUST BE LOCKED IN THE MAXIMUM OPEN POSITION WHEN LIFTING. IT IS UNKNOWN IF THE FACILITY WAS FOLLOWING THE MAINTENANCE AND TRANSFERRING REQUIREMENTS FOR THEIR LIFT.

    Description of Event or Problem · 1

    THE CAREGIVER WAS IN THE PROCESS OF TRANSFERRING A PATIENT USING A PATIENT LIFT, WHEN THE WHEEL ALLEGEDLY FELL OFF THE LIFT, RESULTING IN THE CAREGIVER INJURING HER ARM WHEN SHE CAUGHT THE PATIENT FROM FALLING TO THE FLOOR. THE EXTENT OF THE ALLEGED INJURIES ARE NOT KNOWN AT THIS TIME. THE WORKERS COMPENSATION CLAIM WAS RESOLVED ON (B)(6) 2011.

    Description of Event or Problem · 1

    THE CAREGIVER WAS IN THE PROCESS OF TRANSFERRING A PATIENT USING A PATIENT LIFT, WHEN THE WHEEL ALLEGEDLY FELL OFF THE LIFT, RESULTING IN THE CAREGIVER INJURING HER ARM WHEN SHE CAUGHT THE PATIENT FROM FALLING TO THE FLOOR. THE EXTENT OF THE ALLEGED INJURIES ARE NOT KNOWN AT THIS TIME. THE WORKERS COMPENSATION CLAIM WAS RESOLVED ON (B)(6) 2011.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other