BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE-INTENSIFIED

    MDR report key: 16156675 · Received January 13, 2023

    Report

    Report Number
    16156675
    Event Type
    Malfunction
    Date Received
    January 13, 2023
    Date of Event
    November 16, 2022
    Report Date
    December 27, 2022
    Manufacturer
    PHILIPS MEDICAL SYSTEMS DMC GMBH
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    ANGIO SUITE FLUOROSCOPY AND DIGITAL SUBTRACTION ANGIOGRAPHY IMAGING DELAYED AND DETERIORATED TO NOT SAVING BIPLANE IMAGING BY END OF PROCEDURE. 3D IMAGING OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2074143 SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE-INTENSIFIED JAA PHILIPS MEDICAL SYSTEMS DMC GMBH 68673

    Patients

    Seq Age Sex Outcome Treatment
    1 20075 DA Male