BEUDAMED
    FDA Adverse Event Death Summary report: N

    SIEMENS

    MDR report key: 336722 · Received June 11, 2001

    Report

    Report Number
    336722
    Event Type
    Death
    Date Received
    June 11, 2001
    Date of Event
    June 2, 2001
    Report Date
    June 11, 2001
    Manufacturer
    SIEMENS
    Product Code
    IZO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT IN VERY UNSTABLE CONDITION TRANSFERRED FROM EMERGENCY ROOM TO ANGIO FOR ANGIOGRAM. DURING PROCEDURE, PT CODED. JUST AS PT CODED, MACHINE MONITORS WENT BLANK. AFTER SEVERAL ATTEMPTS TO REBOOT THE SYSTEM, THE PT WAS MOVED TO ANOTHER PROCEDURE ROOM, WHERE THE ANGIOGRAM WAS COMPLETED. UNCERTAIN IF EQUIPMENT FAILURE CONTRIBUTED TO PT'S DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    26585 SIEMENS BIPLANE CINE X-RAY SYSTEM IZO SIEMENS 1617005G2175 *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Death