BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTIS Q BI-PLANE

    MDR report key: 6950800 · Received October 16, 2017

    Report

    Report Number
    6950800
    Event Type
    Malfunction
    Date Received
    October 16, 2017
    Date of Event
    September 6, 2017
    Report Date
    October 4, 2017
    Manufacturer
    SIEMENS HEALTHCARE GMBH
    Product Code
    OWB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING AN ENDOVASCULAR COILING PROCEDURE PERFORMED BY DOCTOR, POOR IMAGE QUALITY DURING THE LIVE FLUORO WAS OBSERVED. UNFORTUNATELY, THERE WERE TIMES WHEN THE PHYSICIAN WAS UNABLE TO SEE THE SYNCRO 2 PRE-SHAPED MICRO WIRE ON THE SCREEN. THE EVENT WAS NOT REPORTED UNTIL LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    732757 ARTIS Q BI-PLANE INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB SIEMENS HEALTHCARE GMBH 10848282

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR