BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTLAB HYPERINFLATION BAG

    MDR report key: 2558123 · Received April 26, 2012

    Report

    Report Number
    2246980-2012-00003
    Event Type
    Malfunction
    Date Received
    April 26, 2012
    Date of Event
    January 25, 2012
    Report Date
    April 26, 2012
    Manufacturer
    VENTLAB CORP.
    Product Code
    NHK
    PMA / PMN Number
    K020281
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE WAS NOT RETURNED AND THE LOT NUMBER NOT PROVIDED FOR OUR INVESTIGATION. ATTEMPTS WERE MADE TO HAVE THE DEVICE RETURNED FOR INVESTIGATION. THERE HAS BEEN NO RESPONSE OR RETURN TO-DATE.

    Description of Event or Problem · 1

    DURING BAGGING OF PT, BAG FAILED AND HOLE WAS TORN IN THE SIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VENTLAB HYPERINFLATION BAG HYPERINFLATION SYSTEM NHK VENTLAB CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1