BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAILY ACTIVITY ASSIST DEVICES

    MDR report key: 2396088 · Received January 4, 2012

    Report

    Report Number
    1525712-2012-00002
    Event Type
    Malfunction
    Date Received
    January 4, 2012
    Report Date
    January 3, 2012
    Manufacturer
    KENSTONE METAL
    Product Code
    IKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)- FACILITY REPRESENTATIVE ALLEGES THAT WHILE A RESIDENT WAS SHOWERING SHE MOVED TO ADJUST HER WEIGHT THE SHOWER CHAIR COLLAPSED. THE PRODUCT WAS RETURNED FOR REGULATORY AFFAIRS INSPECTION. VISUAL INSPECTION: CASTER WHEELS HAD HAIR IN THE BEARING AND WAS COATED WITH SOAP RESIDUE, FLIP-BACK ARMREST BACK STOP HAS EVIDENCE OF CORROSION AND SOAP RESIDUE, AND SEAT RAILS HAD PAINT WORN OFF AND HAD EVIDENCE OF CORROSION. THERE WERE NO DISCREPANCIES WERE OBSERVED DURING FUNCTIONAL TESTING. COMPLAINT WAS NOT CONFIRMED.

    Description of Event or Problem · 1

    THE FACILITY STATES THE CONSUMER SHIFTED HER WEIGHT TO THE RIGHT SIDE TO ALLOW THE CNA TO CLEAN HER, WHEN THE SEAT ALLEGEDLY POPPED UP AND THE CHAIR STARTED TO COLLAPSE. NO INJURY IS ALLEGED, HOWEVER, THE CONSUMER DID HAVE X-RAYS.

    Description of Event or Problem · 1

    THE FACILITY STATES THE CONSUMER SHIFTED HER WEIGHT TO THE RIGHT SIDE TO ALLOW THE CNA TO CLEAN HER, WHEN THE SEAT ALLEGEDLY POPPED UP AND THE CHAIR STARTED TO COLLAPSE. NO INJURY IS ALLEGED, HOWEVER, THE CONSUMER DID HAVE X-RAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DAILY ACTIVITY ASSIST DEVICES 890.5050 IKX KENSTONE METAL 6891

    Patients

    Seq Age Sex Outcome Treatment
    1 Other