BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V-CARE INFANT RESUCITATOR

    MDR report key: 3121827 · Received May 14, 2013

    Report

    Report Number
    MW5030209
    Event Type
    Malfunction
    Date Received
    May 14, 2013
    Date of Event
    May 6, 2013
    Report Date
    May 14, 2013
    Manufacturer
    VENTLAB
    Product Code
    BTM
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    THE V-CARE INFANT RESUSCITATOR BAG FOUND DEFECTIVE - THE DUCK BILL VALVE DID NOT OPEN. THE PROBLEM WAS FOUND BEFORE USAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    213154 V-CARE INFANT RESUCITATOR NEONATAL AMBU BAG BTM VENTLAB VNP3100MB-2B 106470

    Patients

    Seq Age Sex Outcome Treatment
    1