BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASY DIAGNOST ELEVA

    MDR report key: 7994517 · Received October 23, 2018

    Report

    Report Number
    7994517
    Event Type
    Malfunction
    Date Received
    October 23, 2018
    Date of Event
    April 6, 2018
    Report Date
    September 27, 2018
    Manufacturer
    PHILIPS MEDICAL SYSTEMS GMBH DMC, DEVELOPMENT
    Product Code
    KPR
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PER BIO MED, THE COLLIMATOR BULB IN THE X-RAY MACHINE KEEPS GOING OUT, LASTS ONLY THREE TO FOUR MONTHS, SHOULD LAST LONGER. MANUFACTURER RESPONSE FOR LIGHT BULB, RADIOGRAPHIC FLUOROSCOPIC SYSTEM (PER SITE REPORTER). PER BIO MED, MANUFACTURER JUST SENDS OUT REPLACEMENT BULBS TO THE FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    838409 EASY DIAGNOST ELEVA SYSTEM, X-RAY, STATIONARY KPR PHILIPS MEDICAL SYSTEMS GMBH DMC, DEVELOPMENT

    Patients

    Seq Age Sex Outcome Treatment
    1