BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINIX CF

    MDR report key: 2474702 · Received February 27, 2012

    Report

    Report Number
    2474702
    Event Type
    Malfunction
    Date Received
    February 27, 2012
    Date of Event
    January 26, 2012
    Report Date
    February 24, 2012
    Manufacturer
    TOSHIBA AMERICA MEDICAL SYSTEMS, INC.
    Product Code
    MQB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    FAILURE OF TOSHIBA IMAGINE SYSTEM DURING CATHETERIZATION. PATIENT HAD TO BE TRANSPORTED TO THE EP LAB IN ORDER TO COMPLETE THE CASE.MANUFACTURER'S DIAGNOSIS AND SERVICES PERFORMED:1-XX-2012-XX: I CHECKED WITH THE CUSTOMER AND SYSTEM IS FUNCTIONING AS IT SHOULD.1-XX-2012 - XX: THE SYSTEM IS STILL FUNCTIONING AS IT SHOULD. I AM CLOSING THE CASE AS RESOLVED.1-XX-2012-XX: CUSTOMER REPORTED A RAID ERROR AND WAS UNABLE TO PERFORM REC FLUORO. I CONFIRMED THE RAID ERROR AND INABILITY TO AQUIRE IMAGES UPON ARRIVAL.REBOOTING THE SYSTEM DID NOT CLEAR THE ERROR. I RAN THE IMAGE DRIVE STATUS PROGRAM AND THE RAID WAS NOT RECOGNIZED AT ALL.I RESEATED THE MASTER PWB AND ALL THE POWER SUPPLIES IN THE RAID. I RESEATED THE DRIVES IN THE RAID AND THE FIBER CHANNELS. WHEN I REPOWERED THE SYSTEM, THE RAID WAS NORMAL AND I WAS ABLE TO AQUIRE IMAGES IN ALL MODES. SYSTEM PERFORMED NORMAL. I REBOOTED AND PERFORMED AQCUISIONS EACH REBOOT. THE SYSTEM APPEARS TO FUNCTION AS IT SHOULD.I WILL ORDER A MASTER PWB AND A RAID CONTROLLER TO HAVE AVAILABLE IN THE EVENT THE PROBLEM RETURNS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFINIX CF X-RAY SYSTEM, CATH/ANGIO MQB TOSHIBA AMERICA MEDICAL SYSTEMS, INC. INFINIX CF *

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR