BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASY DIAGNOST ELEVA

    MDR report key: 2701963 · Received August 14, 2012

    Report

    Report Number
    3003768251-2012-00020
    Event Type
    Malfunction
    Date Received
    August 14, 2012
    Report Date
    July 16, 2012
    Manufacturer
    PHILIPS MEDICAL SYSTEMS GMBH DMC, DEVELOPMENT AND
    Product Code
    KPR
    PMA / PMN Number
    K031535
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER CHECKED FOR CORRECT OPERATION OF FOOTREST. THE UNIT OPERATED AS EXPECTED. HE COULD NOT FIND ANY SIGN OF DAMAGE THAT MAY HAVE CONTRIBUTED TO SUPPORT DISENGAGING. HOWEVER, THE FIELD SERVICE ENGINEER DECIDED TO REPLACE THE FOOTREST. THE INVESTIGATION SHOWED THAT THE OPERATOR FAILED TO CHECK THE CORRECT LOCKING OF THE FOOTREST INTO PLACE, AS REQUIRED BY THE INSTRUCTIONS FOR USE. THIS IS USE ERROR. THE INSTRUCTIONS FOR USE CLEARLY WARN THE OPERATOR (DANGER!) THAT UPON FOOTREST MOUNTING THE CORRECT LOCKING MUST BE CHECKED, AND DESCRIBES HOW THIS IS TO BE DONE. THE CUSTOMER WAS RETRAINED USING THE FOOTREST ACCORDING TO THE INSTRUCTIONS FOR USE. NO TECHNICAL CORRECTION NEEDED TO BE DONE BECAUSE OF NO MALFUNCTION. THE SYSTEM WORKS AS SPECIFIED. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED ABOUT A DISENGAGED FOOT SUPPORT OF AN X-RAY TABLE. THE TABLE WAS IN THE VERTICAL POSITION, WHEN THE PT STEPPED ON THE FOOTREST, WHICH DROPPED INTO THE BOTTOM POSITION, JARRING THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EASY DIAGNOST ELEVA KPR, JAA KPR PHILIPS MEDICAL SYSTEMS GMBH DMC, DEVELOPMENT AND 706032

    Patients

    Seq Age Sex Outcome Treatment
    1