BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRIS H5000F

    MDR report key: 1942751 · Received December 3, 2010

    Report

    Report Number
    3003768277-2010-00351
    Event Type
    Malfunction
    Date Received
    December 3, 2010
    Date of Event
    November 9, 2010
    Report Date
    November 9, 2010
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    IZI
    PMA / PMN Number
    K971365
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (CONCLUSIONS) - THE CUSTOMER REPORTED THAT THE X-RAY SYSTEM IS SHUTTING DOWN IN MID CASE AND REQUIRES A RESTART. DURING THE INVESTIGATION, THE LOG FILES SHOW THAT THE REBOOT WAS CAUSED BY THE PROJECT CHANGE CONTROL BOARD (PCCB) CARD. AFTER THE REBOOT, THE MACHINE WAS WORKING AGAIN. THE PCCB CARD WAS NOT REPLACED. IN 2010, THIS WAS THE FIRST REPORT REGARDING A RESET CAUSED BY THE PCCB CARD. THERE IS NO NEED FOR MANDATORY FIELD ACTION. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE X-RAY SYSTEM IS SHUTTING DOWN IN MID CASE AND REQUIRES A RESTART.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTEGRIS H5000F IZI (SYSTEM, X-RAY ANGIOGRAPHIC) IZI PHILIPS MEDICAL SYSTEMS 722017 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA