BEUDAMED
    FDA Adverse Event Death Summary report: N

    DIAGNOSTIC ACHIVES

    MDR report key: 22584 · Received March 17, 1995

    Report

    Report Number
    66762-1995-09001
    Event Type
    Death
    Date Received
    March 17, 1995
    Date of Event
    January 18, 1993
    Report Date
    January 27, 1995
    Manufacturer
    DIAGNOSTIC ARCHIVES
    Product Code
    LXJ
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ACCORDING TO THE COMPLAINANT, SURGEON REPORTEDLY FAILED TO COMPLETE A QUADRUPLE AORTACORONARY BYPASS ON PT DUE TO AN ALLEGED BLANK SPOT ON A DISK RECORDED IN THE CATHETERIZATION LAB. THEHE ALLEGED BLANK SPOT WAS REPORTEDLY INTERPRETED AS THE CONCLUSION OF THE FILM SUPPOSEDLY LEADING TO AN ANOMALOUS CIRCUMFLEX ARTERY NOT BEING BYPASSED. IT IS THE ALLEGATION OF THE COMPLAINTANT THAT THIS RESULTED IN A MASSIVE MYOCARDIAL INFARCTION AND THE PT'S DEATH.THE INCIDENT WAS NOT PREVIOUSLY REPORTED AND IS BEING FORWARDED AT THISIME BY THE ATTORNEY FOR THE ADMINISTRIX OF THE ESTATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DIAGNOSTIC ACHIVES OPTICAL DISK LXJ DIAGNOSTIC ARCHIVES 202-124-1 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 * Death OPTICAL DISK SERIES #92085