BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTOPRONE THERAPY

    MDR report key: 2192737 · Received April 25, 2011

    Report

    Report Number
    1625774-2011-00057
    Event Type
    Malfunction
    Date Received
    April 25, 2011
    Date of Event
    March 11, 2011
    Report Date
    April 1, 2010
    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 (B)(4) 2011 AND MET SPECIFICATIONS. THE BED WAS PLACED WITH THE PT ON (B)(6) 2011. ON 01 APRIL 2011, AFTER THE COMPLAINT INVESTIGATION KCI WAS ABLE TO CONFIRM THAT THE BED WOULD NOT ROTATE TO PRONE. THE CAUSE FOR THE MALFUNCTION OF THE BED WAS THE CHASSIS PARALLEL CABLE. THE EXACT NATURE OR CAUSE OF THE MALFUNCTION WITH THE CHASSIS PARALLEL CABLE WAS INDETERMINATE.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE KCI REP REPORTED THAT THE ROTOPRONE HAD A CONTROL ERROR AND REQUIRED THE BED TO BE PLACED BACK TO SUPINE AND LOCK PIN ERROR ALSO CAME UP. THE ERROR COULD NOT BE CLEARED. THERE WAS NO REPORTED PT INJURY. ON 01 APRIL 2011, AFTER THE COMPLAINT INVESTIGATION, KCI WAS ABLE TO CONFIRM 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