BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN

    MDR report key: 1373678 · Received April 30, 2009

    Report

    Report Number
    MW5010947
    Event Type
    Injury
    Date Received
    April 30, 2009
    Report Date
    April 30, 2009
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    ON CERTAIN UNKNOWN DEVICES MANUFACTURED BY PHILIPS MEDICAL SYSTEMS, THE USER DOES NOT HAVE THE CAPABILITY TO RELOAD THE OPERATING SOFTWARE IN THE EVENT OF A CATASTROPHIC SOFTWARE FAILURE. THE EXTENT OF THE DEVICES AFFECTED BY PHILIPS POLICY OF NOT PROVIDING BACKUP SOFTWARE IS UNKNOWN TO THE REPORTER. PHILIPS HAS THAT INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN UNKNOWN MHX PHILIPS MEDICAL SYSTEMS

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| O