BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXIOM ARTIS ZEE BIPLANE MN

    MDR report key: 5837859 · Received August 1, 2016

    Report

    Report Number
    2240869-2016-00662
    Event Type
    Malfunction
    Date Received
    August 1, 2016
    Date of Event
    February 2, 2016
    Report Date
    February 4, 2016
    Manufacturer
    SIEMENS HEALTHCARE, BUSINESS AREA ADVANCED THERAPY
    Product Code
    IZI
    PMA / PMN Number
    K073290
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DURING THE INVESTIGATION, IT WAS DETERMINED THAT THE ROOT CAUSE OF THE EVENT WAS A HARDWARE FAILURE OF THE POWER SUPPLY DFC NIOBE. A NEW POWER SUPPLY WAS INSTALLED AND NO RECURRENCE OF THE ERROR HAS BEEN REPORTED. THIS EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE AXIOM ARTIS ZEE BIPLANE MN SYSTEM. THE CUSTOMER REPORTED THAT THE PLANE A DETECTOR POWER SUPPLY HAD BEEN REPLACED. AFTER FOUR MONTHS, THE DETECTOR FAILED AGAIN. THERE IS NO AWARENESS OF IMPACT TO THE STATE OF HEALTH OF ANY PATIENT INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    491343 AXIOM ARTIS ZEE BIPLANE MN SYSTEM, XRAY, ANGIOGRAPHIC IZI SIEMENS HEALTHCARE, BUSINESS AREA ADVANCED THERAPY 10094143

    Patients

    Seq Age Sex Outcome Treatment
    1