BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTOPRONE THERAPY

    MDR report key: 2142231 · Received May 26, 2011

    Report

    Report Number
    1625774-2011-00066
    Event Type
    Malfunction
    Date Received
    May 26, 2011
    Date of Event
    April 12, 2011
    Report Date
    May 17, 2011
    Manufacturer
    KCI USA, INC.
    Product Code
    IKZ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE BED WAS TESTED PER QUALITY CONTROL PROCEDURES ON 05/31/2011 AND MET SPECIFICATIONS. ON (B)(6) 2011, THE UNIT WAS PLACED WITH THE PATIENT. ON 05/17/2011, KCI'S INITIAL COMPLAINT INVESTIGATION INDICATED THAT THE BED COULD NOT ROTATE TO PRONE.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE KCI REPRESENTATIVE REPORTED THAT THE ROTOPRONE THAT THE DISPLAY SCREEN WAS NOT RESPONDING AND THE NURSE WERE UNABLE TO PRONE THE PATIENT. THERE WAS NO REPORTED PATIENT INJURY. ON 05/17/2011, AFTER THE COMPLAINT INVESTIGATION, KCI WAS ABLE TO DETERMINE THAT THE BED WOULD NOT ROTATE TO PRONE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1