BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POLY G OMCP VISUB CCD (H5000)

    MDR report key: 1942736 · Received December 2, 2010

    Report

    Report Number
    3003768277-2010-00349
    Event Type
    Malfunction
    Date Received
    December 2, 2010
    Date of Event
    November 4, 2010
    Report Date
    November 4, 2010
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    IZI
    PMA / PMN Number
    K984545
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (CONCLUSIONS): THE CUSTOMER REPORTED THAT THE SYSTEM MALFUNCTIONED WHERE THE SYSTEM DOES NOT GENERATE X RAY WHEN NEEDED. THE PROBLEM WAS SOLVED BY REPLACING THE DEFECTIVE X RAY TUBE. EXACT ROOT CAUSE IS UNKNOWN. THE REPLACEMENT OF THIS X RAY TUBE, WHICH MIGHT HAVE CONTRIBUTED OR CAUSED THE REPORTED PROBLEM AND WHICH THEREFORE ARE SUSPECT, HAS SOLVED THE PROBLEM. THIS COMPONENT HAS NO EXCEPTIONAL OR INCREASED FAILURE RATES. IT CANNOT BE PREVENTED THAT SYSTEM COMPONENTS BECOME DEFECTIVE. FAILURE RATES AND RELIABILITY OF COMPONENTS ARE MONITORED. THEREFORE, RISK TO PATIENT REMAINS ACCEPTABLE. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYSTEM MALFUNCTIONED WHERE THE SYSTEM DOES NOT GENERATE X RAY WHEN NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POLY G OMCP VISUB CCD (H5000) IZI (SYSTEM, X-RAY ANGIOGRAPHIC) IZI PHILIPS MEDICAL SYSTEMS 72246 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA