BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MATRX MEDICAL HOPE 5

    MDR report key: 334491 · Received May 23, 2001

    Report

    Report Number
    MW1021956
    Event Type
    Malfunction
    Date Received
    May 23, 2001
    Date of Event
    April 30, 2001
    Report Date
    May 8, 2001
    Manufacturer
    MATRX MEDICAL, INC.
    Product Code
    BTC
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    AMBU BAG RESERVOIR BAG DEVELOPED HOLE DURING BAGGING, MAKING PROCEDURE LESS EFFICIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    24033 MATRX MEDICAL HOPE 5 OXYGEN RESERVOIR FOR HIGH OXYGEN CON BTC MATRX MEDICAL, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR