BEUDAMED
    FDA Adverse Event Other Summary report: N

    ARJO AMBULIFT

    MDR report key: 52776 · Received November 22, 1996

    Report

    Report Number
    1922538-1996-00133
    Event Type
    Other
    Date Received
    November 22, 1996
    Date of Event
    October 24, 1996
    Report Date
    November 21, 1996
    Manufacturer
    ARJO MANUFACTURING CO.
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE HOIST WAS FUNCTION TESTED AND INSPECTED, NO FAULTS WERE FOUND. MARKS WERE FOUND ON THE RIM OF THE TUB WHICH INDICATES THAT THE CHAIR HAD BEEN IN CONTACT WITH THE BATH. USER ERROR. THE CHAIR HAD BEEN LOWERED ONTO THE BATH RIM AND A SUDDEN MOVEMENT WHILE THE RESIDENT WAS BEING DRIED, LED TO THE CHAIR SLIDING OF THE RIM AND THEN FALLING DUE TO SLACKNESS IN THE CHAIN OF THE HOIST. USER HAS BEEN INSTRUCTED TO REVIEW THE OPERATIONAL MANUAL AND A QUOTE HAS BEEN SENT TO THE HOSPITAL FOR A SPRAGG CLUTCH.

    Description of Event or Problem · 1

    HOIST WAS BEING USED TO BATH A MALE RESIDENT. AS HOIST WAS RAISED THE JIB DROPPED. THE CHAIR DID NOT DETACH AND NO INJURY WAS REPORTED. ONE PERSON INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARJO AMBULIFT BSQ FSA ARJO MANUFACTURING CO. AB1402 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other