BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSUFFLATOR 15L

    MDR report key: 41443 · Received September 30, 1996

    Report

    Report Number
    2429304-1996-00004
    Event Type
    Malfunction
    Date Received
    September 30, 1996
    Report Date
    September 9, 1996
    Manufacturer
    NORTECH
    Product Code
    HES
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    OLYMPUS AMERICA INC REC'D A COPY OF THE AUTOPSY REPORT ON THE DECEASED FEMALE. IN THE OPINION OF THE FORENSIC PATHOLOGIST, THE DECEDENT CAME TO HER DEATH AS A RESULT OF PERFORATED ABDOMINAL AORTA WITH MASSIVE HEMOPERITONEUM, THERAPEUTIC MISADVENTURE, ACCIDENTAL. THE COMPLETE AUTOPSY REPORT WILL BE FURNISHED UPON REQUEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSUFFLATOR 15L SURGICAL HI-FLOW INSUFFLATOR 15L #6600 HES NORTECH INSUFFLAT NA

    Patients

    Seq Age Sex Outcome Treatment
    1 *