BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MARK 1

    MDR report key: 1171339 · Received September 17, 2008

    Report

    Report Number
    9617021-2008-00038
    Event Type
    Malfunction
    Date Received
    September 17, 2008
    Date of Event
    May 8, 2008
    Report Date
    September 16, 2008
    Manufacturer
    ARJO MED AB LTD.
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LIFT USED WAS FULLY FUNCTION TESTED BY AN ARJO SERVICE MANAGER ON-SITE WITH THE CUSTOMER; NO FAULT WITH THE EQUIPMENT WAS FOUND. EVEN AFTER SEVERAL ATTEMPTS, THE INVESTIGATOR WAS UNABLE TO REPLICATE THE INCIDENT. THE CAREGIVER IS REPORTED TO HAVE A LAST PRODUCT TRAINING DATE OF "10 YEARS AGO." THE OPERATING AND PRODUCT CARE INSTRUCTIONS FRO THE LIFT CLEARLY STATES, "THE CHAIR, WHICH CAN BE ATTACHED TO/DETACHED FROM THE POOL LIFT, HAS A REMOVABLE SUBCHASSIS. ONLY THE CHAIR IS TO GO INTO THE POOL. TO HELP PREVENT THE ACCIDENTAL RELEASE OF THE CHAIR, A RETAINING CATCH IS FITTED TO THE LEFT HAND "PRONG" OF THE SUB-CHASSIS. WHEN THE CHAIR IS PUSHED ONTO THE CHASSIS, THE CATCH CONNECTS WITH A SLOT IN THE CHAIR FRAME TUBE. PRESS THE CATCH IN TO REMOVE THE CHAIR. IF YOU HAVE A TCS CHAIR, REMOVE THE SUB-CHASSIS. TO HELP THIS ACTION, TAKE THE RESIDENT'S FEET OFF THE FOOT REST BY USING THE LEG REST, IF DESIRED. OPERATE THE CATCH SITUATED UNDER THE LEFT SIDE OF THE SEAT AND GENTLY MOVE THE SUB-CHASSIS BACKWARDS UNTIL FREE." NO INCIDENT HAS BEEN RECORDED WITH THIS TYPE OF COMPLAINT ISSUE ON A POOL LIFT TO DATE. BASED ON THE INFORMATION RECEIVED, IT WOULD APPEAR THAT THE CAREGIVER HAS NOT FOLLOWED THE INSTRUCTIONS OF THE OPI. SINCE THERE COULD BE NO DEFECT FOUND WITH THE LIFT, EVEN AFTER EXTENSIVE ATTEMPTS TO RECREATE THE INCIDENT, THE ROOT CAUSE APPEARS TO BE USER ERROR, MEANING AN ACT OR AN OMISSION OF AN ACT THAT HAS A DIFFERENT RESULT TO THAT INTENDED BY THE MANUFACTURER OR EXPECTED BY THE OPERATOR. THE MANUFACTURER STRONGLY RECOMMENDS THE STAFF AT THE FACILITY BE RETRAINED TO THE LATEST OPI OF THE DEVICE, WITH SPECIAL ATTENTION BEING PAID TO THE SEAT ATTACHMENT.

    Description of Event or Problem · 1

    THE FACILITY REPORTS A YOUNG MALE WAS BEING TRANSFERRED ONTO A FIXED LIFTER USING THE CHAIR/SUB-CHASSIS. DURING THE LIFT, THE CHARI DETACHED FROM THE HOIST AND FELL TO THE FLOOR WITH THE CLIENT IN IT. THE CLIENT HAD PAIN IN THE BOTTOM OF THE HEEL. THE CLIENT WAS TAKEN TO THE A&E AND DISCHARGED AN HOUR LATER. NO SERIOUS INJURIES WERE KNOWN TO DATE. THE LIFT WAS TAKEN OUT OF USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MARK 1 POOL LIFT FSA ARJO MED AB LTD. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR