BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOW INFLATING INFANT AMBU BAG 1/2L HYPERINFLATION SYSTEM WITH MANOMETER

    MDR report key: 8739528 · Received June 26, 2019

    Report

    Report Number
    MW5087643
    Event Type
    Malfunction
    Date Received
    June 26, 2019
    Date of Event
    June 13, 2019
    Report Date
    June 24, 2019
    Manufacturer
    HUDSON RCI, TELEFLEX MEDICAL
    Product Code
    BTM
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    FLOW INFLATING NEONATE AMBU BAG WOULD NOT MAINTAIN PRESSURE DURING POSITIVE PRESSURE VENTILATION. NEW AMBU BAG DEFECTIVE X3 BEFORE FUNCTIONING BAG OBTAINED. NOTED THAT THE WHITE PLASTIC RING AT THE TOP OF THE GREEN FLOW INFLATING BAG WHERE IT MEETS THE CONNECTION THE MANOMETER WAS CRACKED. ENTIRE INVENTORY WAS CHECKED AND AMONG DOZENS OF PRODUCT 15 FROM 4 DIFFERENT LOT NUMBERS WERE FOUND TO BE CRACKED. DISTRIBUTOR WAS CONTACTED AND DEFECTIVE ITEMS WERE REMOVED FROM STOCK. LOT NUMBERS AND NUMBER OF THAT LOT NUMBER THAT WERE FOUND DEFECTIVE: 316763 - 1 BAG, 317232 - 3 BAGS, 317645 - 6 BAGS, 318787 - 5 BAGS. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    531636 FLOW INFLATING INFANT AMBU BAG 1/2L HYPERINFLATION SYSTEM WITH MANOMETER VENTILATOR, EMERGENCY, MANUAL (RESUSCITATION) BTM HUDSON RCI, TELEFLEX MEDICAL 318787
    531640 FLOW INFLATING INFANT AMBU BAG 1/2L HYPERINFLATION SYSTEM WITH MANOMETER VENTILATOR, EMERGENCY, MANUAL (RESUSCITATION) BTM HUDSON RCI, TELEFLEX MEDICAL 316763
    531641 FLOW INFLATING INFANT AMBU BAG 1/2L HYPERINFLATION SYSTEM WITH MANOMETER VENTILATOR, EMERGENCY, MANUAL (RESUSCITATION) BTM HUDSON RCI, TELEFLEX MEDICAL 317645
    531642 FLOW INFLATING INFANT AMBU BAG 1/2L HYPERINFLATION SYSTEM WITH MANOMETER VENTILATOR, EMERGENCY, MANUAL (RESUSCITATION) BTM HUDSON RCI, TELEFLEX MEDICAL 317645
    531643 FLOW INFLATING INFANT AMBU BAG 1/2L HYPERINFLATION SYSTEM WITH MANOMETER VENTILATOR, EMERGENCY, MANUAL (RESUSCITATION) BTM HUDSON RCI, TELEFLEX MEDICAL 317232
    531644 FLOW INFLATING INFANT AMBU BAG 1/2L HYPERINFLATION SYSTEM WITH MANOMETER VENTILATOR, EMERGENCY, MANUAL (RESUSCITATION) BTM HUDSON RCI, TELEFLEX MEDICAL 317232
    531645 FLOW INFLATING INFANT AMBU BAG 1/2L HYPERINFLATION SYSTEM WITH MANOMETER VENTILATOR, EMERGENCY, MANUAL (RESUSCITATION) BTM HUDSON RCI, TELEFLEX MEDICAL 317232
    531646 FLOW INFLATING INFANT AMBU BAG 1/2L HYPERINFLATION SYSTEM WITH MANOMETER VENTILATOR, EMERGENCY, MANUAL (RESUSCITATION) BTM HUDSON RCI, TELEFLEX MEDICAL 317645
    531647 FLOW INFLATING INFANT AMBU BAG 1/2L HYPERINFLATION SYSTEM WITH MANOMETER VENTILATOR, EMERGENCY, MANUAL (RESUSCITATION) BTM HUDSON RCI, TELEFLEX MEDICAL 317645
    531648 FLOW INFLATING INFANT AMBU BAG 1/2L HYPERINFLATION SYSTEM WITH MANOMETER VENTILATOR, EMERGENCY, MANUAL (RESUSCITATION) BTM HUDSON RCI, TELEFLEX MEDICAL 317645
    531649 FLOW INFLATING INFANT AMBU BAG 1/2L HYPERINFLATION SYSTEM WITH MANOMETER VENTILATOR, EMERGENCY, MANUAL (RESUSCITATION) BTM HUDSON RCI, TELEFLEX MEDICAL 317645
    531650 FLOW INFLATING INFANT AMBU BAG 1/2L HYPERINFLATION SYSTEM WITH MANOMETER VENTILATOR, EMERGENCY, MANUAL (RESUSCITATION) BTM HUDSON RCI, TELEFLEX MEDICAL 318787
    531651 FLOW INFLATING INFANT AMBU BAG 1/2L HYPERINFLATION SYSTEM WITH MANOMETER VENTILATOR, EMERGENCY, MANUAL (RESUSCITATION) BTM HUDSON RCI, TELEFLEX MEDICAL 318787
    531652 FLOW INFLATING INFANT AMBU BAG 1/2L HYPERINFLATION SYSTEM WITH MANOMETER VENTILATOR, EMERGENCY, MANUAL (RESUSCITATION) BTM HUDSON RCI, TELEFLEX MEDICAL 318787
    531653 FLOW INFLATING INFANT AMBU BAG 1/2L HYPERINFLATION SYSTEM WITH MANOMETER VENTILATOR, EMERGENCY, MANUAL (RESUSCITATION) BTM HUDSON RCI, TELEFLEX MEDICAL 318787

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DA