BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRIS CV

    MDR report key: 1942666 · Received December 8, 2010

    Report

    Report Number
    3003768277-2010-00358
    Event Type
    Malfunction
    Date Received
    December 8, 2010
    Date of Event
    November 15, 2010
    Report Date
    November 15, 2010
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    IZI
    PMA / PMN Number
    K984545
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSIONS: THE INVESTIGATION FOUND A DEFECTIVE INTERFACE BOARD ((B)(4)). HOWEVER, THE EXACT ROOT CAUSE IS NOT KNOWN. THIS BOARD (WHICH MIGHT HAVE CONTRIBUTED OR CAUSED THE REPORTED PROBLEM) REPLACEMENT FIXED THE PROBLEM. FAILURE RATES AND RELIABILITY OF COMPONENTS ARE MONITORED AND THIS BOARD HAS NO EXCEPTIONAL OR INCREASED FAILURE RATE. THERE IS NO REQUIRED MANDATORY FIELD ACTION.

    Description of Event or Problem · 1

    THIS X-RAY SYSTEM DID NOT HAVE FLUORO OR CHINE FUNCTIONALITY WHILE A PT WAS ON THE TABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTEGRIS CV IZI (SYSTEM, X-RAY, ANGIOGRAPHIC) IZI PHILIPS MEDICAL SYSTEMS 722030 NA

    Patients

    Seq Age Sex Outcome Treatment
    1