BEUDAMED
    FDA Adverse Event Other Summary report: N

    SC/ADVANTX

    MDR report key: 104310 · Received July 7, 1997

    Report

    Report Number
    104310
    Event Type
    Other
    Date Received
    July 7, 1997
    Date of Event
    January 16, 1997
    Report Date
    July 1, 1997
    Manufacturer
    GE MEDICAL SYSTEMS
    Product Code
    IZO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IN, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    1/16 DURING PTCA C-ARM MALFUNCTIONED-RIGHT PTCA COMPLETED-DUE TO MALFUNCTION OF C-ARM, LEFT LAD PTCA COULD NOT BE DONE. PTCA ABORTED. 1/18 RETURNED TO CATH LAB 1/18 FOR REPEAT PTCA OF LAD-ARRESTED FOLLOWING 2ND PTCA AND DID NOT RESPOND TO ACLS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SC/ADVANTX HEART CATH LAB IZO GE MEDICAL SYSTEMS SC/ADVANTX *

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Other