BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTOPRONE THERAPY SYSTEM

    MDR report key: 1702244 · Received May 17, 2010

    Report

    Report Number
    1625774-2010-00039
    Event Type
    Malfunction
    Date Received
    May 17, 2010
    Date of Event
    April 17, 2010
    Report Date
    April 17, 2010
    Manufacturer
    KCI USA, INC.
    Product Code
    IKZ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION OF THE BED CONCLUDED THAT THE RESPONSE FROM THE CONTROL PANEL WAS DUE TO A DAMAGED CABLE AND CORROSION ON THE INTERFACE BOARD FROM AN UNKNOWN SOURCE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ROTOPRONE THERAPY SYSTEM ALLEGEDLY MALFUNCTIONED. IT WAS REPORTED THAT THE BED WENT INTO POWERED CPR MODE WITHOUT COMMAND WHICH CAUSES THE BED TO MOVE TO THE ZERO SUPINE. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ROTOPRONE THERAPY SYSTEM IKZ KCI USA, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1