BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIRFLOW

    MDR report key: 7048052 · Received November 21, 2017

    Report

    Report Number
    2246980-2017-00032
    Event Type
    Malfunction
    Date Received
    November 21, 2017
    Date of Event
    October 12, 2017
    Report Date
    October 23, 2017
    Manufacturer
    VENTLAB LLC.
    Product Code
    BTM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUSPECT DEVICE WAS VISUALLY INSPECTED, THE DEVICE DID NOT MATCH THE PROBLEM DESCRIPTION THE CUSTOMER PROVIDED, THE DIAPHRAGM ON THE RETURNED PART WAS CORRECTLY SEATED. THE DEVICE WAS ALSO CHECKED FOR FUNCTIONALITY, IN WHICH THE DEVICE PERFORMED AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGES THAT "RESERVOIR VALVE IS FAULTY." NO OTHER DETAILS WERE PROVIDED AND NO PATIENT INJURY/HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    830848 AIRFLOW RESUS BAG BTM VENTLAB LLC. CPRM1126FM 310001

    Patients

    Seq Age Sex Outcome Treatment
    1