BEUDAMED
    FDA Adverse Event Death Summary report: N

    DCI

    MDR report key: 120722 · Received September 15, 1997

    Report

    Report Number
    1217116-1997-00031
    Event Type
    Death
    Date Received
    September 15, 1997
    Date of Event
    August 12, 1997
    Report Date
    August 15, 1997
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    LMD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REPORTEDLY, THE DCI HAD LOCKED UP. THEREFORE, DIGITAL CINE IMAGING COULD NOT BE ENABLED. THE PT WAS PLACED ON THE TABLE AND THE SYSTEM AUXILIARY FOR REGULAR CINE WAS THEN SELECTED TO ENABLE REGULAR CINE IMAGING. THE PT HAD A CATHETER INSERTED AND ALLEGEDLY THE PT THEN CODED AND SUBSEQUENTLY DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DCI DIGITAL CARDIAC IMAGING SYSTEM LMD PHILIPS MEDICAL SYSTEMS NI NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Death