BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PHILIPS MEDICAL SYSTEM

    MDR report key: 545533 · Received July 26, 2004

    Report

    Report Number
    MW1032871
    Event Type
    Malfunction
    Date Received
    July 26, 2004
    Date of Event
    May 13, 2004
    Report Date
    July 26, 2004
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    DRS
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    CARDIAC CATH LAB EQUIPMENT: 2004 "GENERATOR UNAVAILABLE" ERROR. 2004 SAME ERROR. 2004 SAME ERROR X 7, 2004 BOOT FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PHILIPS MEDICAL SYSTEM CARDIAC CATH EQUIPMENT DRS PHILIPS MEDICAL SYSTEMS 105658 INTEGRIS ACCURA *

    Patients

    Seq Age Sex Outcome Treatment
    1 *