BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTOPRONE THERAPY SYSTEM

    MDR report key: 1934298 · Received November 24, 2010

    Report

    Report Number
    1625774-2010-00106
    Event Type
    Malfunction
    Date Received
    November 24, 2010
    Date of Event
    October 26, 2010
    Report Date
    October 26, 2010
    Manufacturer
    KCI USA, INC.
    Product Code
    IKZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE BED WAS TESTED PER QUALITY CONTROL PROCEDURES ON (B)(4) 2010 AND MET SPECIFICATIONS PRIOR TO PT PLACEMENT. THE BED WAS RETURNED TO KCI ON (B)(4) 2010 FOR EVALUATION. EVALUATION OF THE BED DETERMINED THAT THE FOOT JACK MOTOR WAS MALFUNCTIONING CAUSING THE BED THE INABILITY TO SUPINE AND THEN ROTATE TO PRONE THE PT. THE FOOT JACK MOTOR WAS REPLACED.

    Description of Event or Problem · 1

    ON (B)(4) 2010, THE NURSE REPORTED THAT THE BED WOULD NOT PRONE. AS AN ALTERNATIVE TO PRONGING THE PT, THE NURSE PLACED THE PT IN REVERSE TRENDELENBURG. THE BED DID NOT EXECUTE THE SUPINE POSITION AS EXPECTED BY THE NURSE. THE BED WOULD NOT LOWER ALL THE WAY AND THE SCREEN WOULD NOT CHANGE IN ORDER TO PRESS THE PRONE BUTTON. THE BED WOULD NOT RESET IN ORDER TO PRONE THE PT. THE PT HAD BEEN ON THE ROTOPRONE BED FROM 16 OCT TO (B)(4) 2010. THERE WAS NO REPORTED INJURY OR HARM WITH THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1