BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PHILIPS

    MDR report key: 8145982 · Received December 10, 2018

    Report

    Report Number
    8145982
    Event Type
    Malfunction
    Date Received
    December 10, 2018
    Date of Event
    November 12, 2018
    Report Date
    December 4, 2018
    Manufacturer
    PHILIPS MEDICAL SYSTEMS, INC.
    Product Code
    LNH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE DEVICE QUENCHED WITHOUT ANY IDENTIFIABLE CAUSE, WHICH TOOK IT OUT OF SERVICE FOR A PERIOD OF WEEKS. PER MANUFACTURER RESPONSE TO THE HOSPITAL, THE DEVICE IS BEING REPAIRED (UNSURE OF THE CAUSE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    986908 PHILIPS SYSTEM, NUCLEAR MAGNETIC RESONANCE LNH PHILIPS MEDICAL SYSTEMS, INC. INGENIA 3.0T

    Patients

    Seq Age Sex Outcome Treatment
    1