BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLURA XPER FD20

    MDR report key: 1942677 · Received December 8, 2010

    Report

    Report Number
    3003768277-2010-00360
    Event Type
    Malfunction
    Date Received
    December 8, 2010
    Date of Event
    August 5, 2010
    Report Date
    August 5, 2010
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    IZI
    PMA / PMN Number
    K031333
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSIONS - THE INVESTIGATION FOUND THAT BASED ON THE INITIAL COMPLAINT TEXT THE USER DID NOT UNDERSTAND THE ERROR MESSAGE DISPLAYED ON THE SCREEN. THEREFORE, IT WAS INITIALLY CONCLUDED A USER ERROR. HOWEVER, IT WAS FOUND ON RETROSPECTIVE REVIEW THAT THERE WAS A HARDWARE DEFECT INDICATING THAT THIS INITIAL ASSESSMENT WAS INCORRECT. IT WAS FOUND THE SYSTEM MALFUNCTIONED DUE TO A CONTACT FAILURE IN THE MAIN CABINET. THIS ERROR RESULTED IN A COMMUNICATION PROBLEM WHERE THE MAIN CABINET FAILED TO TELL THE VELARA GENERATOR TO TURN ON. THE ROOT CAUSE WAS A FAULTY CABLE CONNECTOR. THIS IS THE FIRST OCCURRENCE FOR THIS TYPE OF PROBLEM. THERE IS NO REQUIRED MANDATORY FIELD ACTION.

    Description of Event or Problem · 1

    THIS X-RAY SYSTEM WAS NOT AVAILABLE FOR USE WITH THE DISPLAYED ERROR, "EXPOSURE NOT POSSIBLE RESELECT APPLICATION." THE USER STATES THE PT AT RISK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALLURA XPER FD20 IZI (SYSTEM, X-RAY, ANGIOGRAPHIC) IZI PHILIPS MEDICAL SYSTEMS 722006 NA

    Patients

    Seq Age Sex Outcome Treatment
    1