BEUDAMED
    FDA Adverse Event Death Summary report: N

    LFX GENERATOR

    MDR report key: 165583 · Received April 27, 1998

    Report

    Report Number
    6000088-1998-00007
    Event Type
    Death
    Date Received
    April 27, 1998
    Date of Event
    April 11, 1998
    Report Date
    April 24, 1998
    Manufacturer
    GENERAL ELECTRIC CO.
    Product Code
    IZO
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO GE THAT A PT UNDERGOING PERCUTANEOUS TRANSLUMINAL CARDIAC ANGIOPLASTY (PTCA) WENT INTO CARDIAC ARREST AFTER APPROXIMATELY TWO HOURS AND CPR WAS INITIATED. TWENTY MINUTES LATER, THE SYSTEM WOULD NO LONGER IMAGE AND ATTEMPTS TO IMAGE PROCEEDED FOR FORTY MINUTES. REPORTEDLY, A MOBILE FLUOROSCOPIC UNIT WAS BROUGHT IN AT WHICH TIME THE PT WAS PRONOUNCED DEAD. THE SYSTEM WAS EVALUATED, REPAIRED AND RETURNED TO SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LFX GENERATOR DIAGNOSTIC X-RAY IZO GENERAL ELECTRIC CO. 46-275911G8 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Death