BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETAC SWIFT MOBIL

    MDR report key: 2939583 · Received December 18, 2012

    Report

    Report Number
    3008986539-2012-00076
    Event Type
    Malfunction
    Date Received
    December 18, 2012
    Date of Event
    September 1, 2012
    Report Date
    September 24, 2012
    Manufacturer
    ETAC SUPPLY CENTER AB
    Product Code
    INM
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THERE ARE TWO ORANGE BOLTS (ADJUSTMENT PINS) WHICH ATTACHES THE SEAT FRAME TO THE LOWER FRAME OF THE CHAIR. INVESTIGATION OF THE PRODUCT SHOWS THAT THE LEFT SIDE BOLT IS BROKEN INTO TWO PIECES. ETAC SUPPLY CENTER AB HAS TRIED TO RECREATE THE EVENT. IF THE BOLT IS FIXED IN PLACE IT'S NOT POSSIBLE TO RECREATE THE EVENT. BUT IF THE BOLT HAS NOT ENTERED PROPERLY INTO THE TWO FRAMES THE BOLT COULD BREAK. OUR CONCLUSION IS THAT HEIGHT ADJUST PIN HAS BEEN ASSEMBLED IN A WRONG WAY. THE MANUAL FOR SHOWER CHAIR SHOWS HOW TO ASSEMBLE THE BOLT CORRECTLY. RISK ANALYSIS HAS BEEN PERFORMED FOR THE PRODUCT. THE HAZARD WITH BOLTS BREAKING ARE HANDLE IN THE RISK ANALYSIS. THE RISK IS CONSIDERED ACCEPTABLE.

    Description of Event or Problem · 1

    A NURSE TOOK THE PT TO A SHOWER, THE NURSE WAS WASHING THE PT'S FEET (TOES). THERE WAS LOUD NOISE AND BOTH THE SHOWER CHAIR AND THE PT FELL TO THE FLOOR (LEFT SIDE). THE LEFT HAND SHOULDER AND THE SIDE WERE HURT, ALSO THE LEFT ARM STAYED UNDER THE HEMI ARM REST. THE SEAT HEIGHT WAS AT THE HIGHEST LEVEL. HEIGHT ADJUSTMENT PIN (ORANGE, LEFT SIDE) WAS BROKEN. X-RAY SHOWED NO INJURIES.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR