BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE-INTENSIFIED

    MDR report key: 7006301 · Received November 7, 2017

    Report

    Report Number
    7006301
    Event Type
    Malfunction
    Date Received
    November 7, 2017
    Date of Event
    August 2, 2017
    Report Date
    September 29, 2017
    Manufacturer
    SIEMENS HEALTHCARE GMBH
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    C-ARM STOPPED FUNCTIONING DURING CARDIAC CATHETERIZATION PROCEDURE. DEVICE WAS UNABLE TO BE ROTATED. THE C-ARM WAS REBOOTED AND FUNCTIONED APPROPRIATELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    787318 SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE-INTENSIFIED JAA SIEMENS HEALTHCARE GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1