BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRIS H3000

    MDR report key: 1959768 · Received December 28, 2010

    Report

    Report Number
    3003768277-2010-00402
    Event Type
    Malfunction
    Date Received
    December 28, 2010
    Date of Event
    December 1, 2010
    Report Date
    December 1, 2010
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    IZF
    PMA / PMN Number
    K925302
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (METHOD, RESULTS, CONCLUSIONS) - THE INVESTIGATION IS STILL ONGOING ON THIS EVENT. WHEN THE INVESTIGATION IS COMPLETED, A F/U REPORT WILL BE SENT TO THE FDA.

    Description of Event or Problem · 1

    THIS X-RAY WAS FOUND TO HAVE DETECTABLE GROUND LEAKAGE VOLTAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTEGRIS H3000 IZF (SYSTEM, X-RAY, TOMOGRAPHIC) IZF PHILIPS MEDICAL SYSTEMS 72238 NA

    Patients

    Seq Age Sex Outcome Treatment
    1