BEUDAMED
    FDA Adverse Event Death Summary report: N

    DRV VALVE

    MDR report key: 100393 · Received June 23, 1997

    Report

    Report Number
    100393
    Event Type
    Death
    Date Received
    June 23, 1997
    Date of Event
    June 10, 1997
    Report Date
    June 23, 1997
    Manufacturer
    NOVA VENTRX, INC.
    Product Code
    CBP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT WITH DIAGNOSIS OF SIGMOID COLON CANCER ADMIT FOR RESECTION. NEEDLE BIOPSY OF LIVER REVEALED METASTASIS. PROCEDURE COMPLETED & PT MOVED FORM TABLE TO BED. ANESTHESIA MACHINE DISCONNECTED. ANESTHESIOLOGIST ATTEMPTED TO HAND VENTILATE W/AMBU BAG, EXPIRATORY VALVE APPEARED STUCK CLOSED. BAG CHANGED BUT PT BECAME CYANOTIC AND BRADYCARDIAC. FURTHER RESUSCITATION WAS UNSUCCESSFUL AND PT EXPIRED AT 1445. AMBU BAG AND VALVE SENT TO OUTSIDE CO FOR OBJECTIVE ANALYSIS. NO REPORT AS YET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DRV VALVE VALVE FOR NON-DISPOSABLE AMBU BAG CBP NOVA VENTRX, INC. 3011 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Death ET TUBE