BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRIS HM3000

    MDR report key: 1872881 · Received September 29, 2010

    Report

    Report Number
    3003768277-2010-00213
    Event Type
    Malfunction
    Date Received
    September 29, 2010
    Date of Event
    August 23, 2010
    Report Date
    August 23, 2010
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    IZF
    PMA / PMN Number
    K925302
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (EVAL METHOD, RESULTS, CONCLUSIONS): THE INVESTIGATION IS STILL ONGOING ON THIS EVENT. WHEN THE INVESTIGATION IS COMPLETED A FOLLOW-UP REPORT WILL BE SENT TO THE FDA.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTS THAT AT THE END OF A PATIENT PROCEDURE THE X-RAY SYSTEM SHUT OFF ON ITS OWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTEGRIS HM3000 IZF (SYSTEM, X-RAY, TOMOGRAPHIC) IZF PHILIPS MEDICAL SYSTEMS 72239 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA