BEUDAMED
    FDA Adverse Event Other Summary report: N

    ARJO AMBULIFT

    MDR report key: 38266 · Received September 11, 1996

    Report

    Report Number
    1922538-1996-00093
    Event Type
    Other
    Date Received
    September 11, 1996
    Date of Event
    September 4, 1996
    Report Date
    September 11, 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 FOLLOWING IS THE CLOSING OUT REPORT FROM FOREIGN REPORTER. EXAMINATION: SEAT SHELL WAS RETURNED. UNDERSIDE OF SHELL WAS HEAVILY CONTAMINATED. EXAMINATION RESTRICTED TO VISUAL ONLY. THE UNDERSIDE RETAINING RIBS SHOW EVIDENCE OF DISTORTION & BRUISING DUE TO BAD FITTING DURING CUSTOMER USE. THE DISTORTION ON RIB GAVE THE IMPRESSION THAT IT WOULD NOT CLIP ONTO THE CHAIR FRAME. CONCLUSIONS: THE SECURITY OF THE SEAT SHELL HAD BEEN SERIOUSLY IMPAIRED BY BAD FITTING, DUE TO USER ERROR IN MAINTENANCE. THIS IN TURN WAS MOST PROBABLY THE REASON FOR DETACHMENT.

    Description of Event or Problem · 1

    ONE PERSON INVOLVED. IS NOT ON FILE FOR TEXT COPY. ENTER TEXT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARJO AMBULIFT PATIENT HOIST FSA ARJO MANUFACTURING CO. AB1004 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Other