BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MOBILE DIAGNOSTIC WDR

    MDR report key: 8154632 · Received December 12, 2018

    Report

    Report Number
    8154632
    Event Type
    Malfunction
    Date Received
    December 12, 2018
    Date of Event
    November 26, 2018
    Report Date
    December 4, 2018
    Manufacturer
    PHILIPS MEDICAL SYSTEMS, INC.
    Product Code
    IZL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    BACK UP ON PORTABLE X-RAY MACHINE MALFUNCTIONED AND WOULD NOT TURN OFF. POTENTIAL TO INJURE STAFF OR PATIENTS IF THEY WERE HIT BY THIS DEVICE. PER MANUFACTURER RESPONSE TO THE HOSPITAL, DMC BOARD REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    996079 MOBILE DIAGNOSTIC WDR X-RAY, MACHINE, PORTABLE IZL PHILIPS MEDICAL SYSTEMS, INC. 9890-010-89522

    Patients

    Seq Age Sex Outcome Treatment
    1