BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXILIFT

    MDR report key: 1079495 · Received July 16, 2008

    Report

    Report Number
    9617021-2008-00027
    Event Type
    Malfunction
    Date Received
    July 16, 2008
    Date of Event
    October 12, 2007
    Report Date
    July 16, 2008
    Manufacturer
    ARJO MED AB LTD.
    Product Code
    FNG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN ARJO INVESTIGATOR VISITED THE FACILITY TO INSPECT AND TEST THE LIFTER INVOLVED IN THE REPORTED INCIDENT. THE REPORT STATES THE LIFTER WAS ABOUT 13 YEARS OLD WITH COMMENSURATE WEAR AND TEAR. THE JIB AND JIB CAP HAD PAINT MARKING ON THEM, INDICATING CONTACT WITH OTHER OBJECTS. THE PATIENT WAS SCRATCHED OFF THE LEGS. THE LIFT MOTOR AND GEARBOX HAD SEPARATED FROM THE MAST. SOME PARTS WERE MISSING; THE SCREWS WERE NOT STRIPPED OUT. THE LIFTER WAS NOT IN WORKING ORDER. THE SLING USED, WAS TWO YEARS OLD AND IN A GOOD CONDITION WITH NO FAULTS REPORTED. THE LIFTER WAS LAST SERVICED BY ARJO IN EARLY 2007. BASED UPON THE REPORT AND PHOTOGRAPHS TAKEN, THE EXACT CAUSE OF THE REPORTED INCIDENT REMAINS UNK. THIS IS THE FIRST REPORTED CASE OF THIS TYPE OF FAILURE ON RECORD AND IS SEEN AS AN ISOLATED CASE. HOWEVER, AT SOME STAGE, IT IS POSSIBLE THE FOUR BOLTS WERE EITHER NOT TIGHTENED OR OVER TIGHTENED. IF NOT CORRECTLY TIGHTENED, THE BOLTS MAY HAVE WORKED LOOSE, OR IF OVER TIGHTENED, MAY HAVE STRIPPED/DAMAGED THE THREADS IN THE MAST. IN EITHER CASE, IT MAY WELL HAVE RESULTED IN THE REPORTED INCIDENT. THE MANUFACTURER RECOMMENDS THAT ARJO FULL SERVICE/REPAIR THIS LIFTER, PAYING PARTICULAR ATTENTION TO THE FOUR THREADED HOLES WITHIN THE TOP OF THE MAIN MAST THAT RETAIN THE MOTOR/GEARBOX IN PLACE. IF ANY EVIDENCE OF THREAD STRIPPING HAS TAKEN PLACE, THE MAIN MAST MUST BE REPLACED. IT IS ALSO RECOMMENDED THAT WHOEVER LAST SERVICED THE LIFTER BE ADVISED OF THIS INCIDENT AND REMINDED TO CHECK ALL FIXINGS, ETC. AS PER THE PM SCHEDULE. AS NO OPERATING OR PM SCHEDULE WERE AVAILABLE AT THE FACILITY, COPIES NEED TO BE PROVIDED TO THEM.

    Description of Event or Problem · 1

    THE FACILITY REPORTS THE CAREGIVER PUT THE RESIDENT IN THE SLING AND LOCKED THE SLING TO THE LIFT. THE CAREGIVER THEN PUSHED THE UP BUTTON TO RAISE THE RESIDENT. THE LIFT BEGAN MOVING UP, THEN STOPPED AND FELL DOWN, DROPPING THE RESIDENT BACK TO THE BED. THE LIFT COMPLETELY FELL APART. NO INJURIES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAXILIFT PATIENT LIFT FNG ARJO MED AB LTD. KMBXXXX

    Patients

    Seq Age Sex Outcome Treatment
    1