BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESUSCITATION BAG

    MDR report key: 4301330 · Received October 30, 2014

    Report

    Report Number
    2246980-2014-00051
    Event Type
    Injury
    Date Received
    October 30, 2014
    Date of Event
    August 4, 2014
    Report Date
    October 30, 2014
    Manufacturer
    VENTLAB CORP.
    Product Code
    BTM
    PMA / PMN Number
    K012842
    Removal / Correction Number
    RES68242
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE AFFECTED DEVICE WAS NOT AVAILABLE FOR INVESTIGATION. HOWEVER, VENTLAB PERFORMED QUALITY TRENDING, PRODUCT INVESTIGATION AND CORRECTIVE ACTIONS TO SOLVE THE ROOT CAUSES. THE SOLUTIONS WERE IMPLEMENTED LAST YEAR AND A RECALL WAS INITIATED IN MAY OF THIS YEAR.

    Description of Event or Problem · 1

    DUCKBILL VALVE FAILED TO OPEN DURING RESUSCITATION OF PT. PHYSICIAN SQUEEZED BAG VERY HARD AND POP OFF POPPED UP. PHYSICIAN WAS ALERTED TO THE FAILURE OF THE BAG AND USED A DIFFERENT BAG TO DELIVER AIR TO PT. NO HARM TO PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    696620 RESUSCITATION BAG MANUAL RESUSCITATOR BTM VENTLAB CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention