BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETAC SWIFT MOBIL

    MDR report key: 3080682 · Received April 8, 2013

    Report

    Report Number
    3008986539-2013-00009
    Event Type
    Malfunction
    Date Received
    April 8, 2013
    Date of Event
    November 7, 2012
    Report Date
    November 14, 2012
    Manufacturer
    ETAC SUPPLY CENTER AB
    Product Code
    INM
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS NOT RETURNED TO ETAC SUPPLY CENTER (B)(4). A PHOTO OF THE BROKEN PART, HEIGHT ADJUSTMENT PIN, WAS SENT TO ETAC AND IT SHOWS THAT THE PART IS BROKEN INTO TWO PIECES. THERE ARE TWO ORANGE HEIGHT ADJUSTMENT PINS ON THE SHOWER CHAIR. THEY ATTACH THE SEAT FRAME TO THE LOWER FRAME OF THE CHAIR. ETAC SUPPLY CENTER (B)(4) HAS TRIED TO RECREATE THE EVENT. IF THE HEIGHT ADJUSTMENT PIN IS FIXED IN PLACE IT'S NOT POSSIBLE TO RECREATE THE EVENT. BUT IF THE HEIGHT ADJUSTMENT PIN HAS NOT ENTERED PROPERLY INTO THE TWO FRAMES THE HEIGHT ADJUSTMENT PIN COULD BREAK. THE BREAK WILL BE SIMILAR TO THE ONE OF THE PHOTO. OUR CONCLUSION IS THAT THE HEIGHT ADJUSTMENT PIN HAS BEEN ASSEMBLED IN A WRONG WAY (NOT ENTERED PROPERLY INTO THE TWO FRAMES). THE MANUAL FOR THE SHOWER CHAIR SHOWS HOW TO ASSEMBLE THE HEIGHT ADJUSTMENT PIN CORRECTLY. RISK ANALYSIS HAS BEEN PERFORMED FOR THE PRODUCT. THE HAZARD WITH HEIGHT ADJUSTMENT PIN BREAKING ARE HANDLED IN THE RISK ANALYSIS. THE RISK IS CONSIDERED ACCEPTABLE.

    Description of Event or Problem · 1

    THE ORANGE PART THAT SUBJECTS THE HEIGHT REGULATION (ITEM NO. (B)(4)) HAS BROKEN WHILE THE CHAIR WAS USED. AS A CONSEQUENCE, THE USER HAS FALLEN DOWN TO THE FLOOR. NO INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    144335 ETAC SWIFT MOBIL CHAIR, WITH CASTERS - INM INM ETAC SUPPLY CENTER AB 80209410

    Patients

    Seq Age Sex Outcome Treatment
    1