BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMBU BAG

    MDR report key: 33108 · Received May 22, 1996

    Report

    Report Number
    MW1009144
    Event Type
    Injury
    Date Received
    May 22, 1996
    Date of Event
    May 7, 1996
    Report Date
    May 13, 1996
    Manufacturer
    VITAL SIGNS, INC.
    Product Code
    BTM
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    VITAL SIGNS, INC. 20 CAMPUS RD, TOTOWA, NJ 07512. OF THE 22,000 ELBOW'S MOLDED DURING THIS LOT CONTROL RUN, ONLY ONE HAS EXHIBITED THIS CONDITION. THIS CONCLUSION WAS DRAWN FROM THE RESULTS OF INSPECTIONS PERFORMED ON STATISTICALLY SIGNIFICANT LARGE QUANTITIES OF COMPONENTS FROM THIS ACTUAL LOT CONTROL NUMBER AT A SAMPLE INSPECTION LEVEL OF C=O, AQL=0.10%.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMBU BAG RESUSCITATOR BAG BTM VITAL SIGNS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 4 MO Required Intervention