BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHILIPS

    MDR report key: 204889 · Received January 6, 1999

    Report

    Report Number
    204889
    Event Type
    Injury
    Date Received
    January 6, 1999
    Date of Event
    January 4, 1999
    Report Date
    January 6, 1999
    Manufacturer
    PHILIPS MEDICAL
    Product Code
    IZO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    CRITICALLY ILL PT IN CARDIAC CATHERIZATION LAB UNDERGOING DIAGNOSTIC PROCEDURE TO DETERMINE LOCATION OF DISSECTING ANEURYSM WHEN THE EQUIPMENT FAILED, - SHUT SELF DOWN REQUIRING TRANSFER OF PT TO A SECOND CATHERIZATION LAB. THE EQUIPMENT FAILED AT 0112. TRANSFERRED TO SECOND ROOM WHEN PT WENT INTO ELECTROMECHANICAL DISSOCIATION. CODED AT 0128. UNSUCCESSFUL RESUSCITATION EFFORTS. PRONOUNCED AT 0143.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PHILIPS X-RAY IZO PHILIPS MEDICAL V-5000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Life Threatening| O