BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIRFLOW

    MDR report key: 7063604 · Received November 28, 2017

    Report

    Report Number
    2246980-2017-00033
    Event Type
    Malfunction
    Date Received
    November 28, 2017
    Report Date
    November 1, 2017
    Manufacturer
    VENTLAB LLC.
    Product Code
    BTM
    PMA / PMN Number
    K012842
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DURING THE COURSE OF THE PRODUCT INVESTIGATION, VISUAL AND FUNCTIONAL TESTING WAS PERFORMED ON THE RETURNED PRODUCT. THE INVESTIGATION CONFIRMED THE CUSTOMER CLAIM AND A NONCONFORMANCE HAS BEEN OPENED TO GARNER FURTHER INVESTIGATION.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGES THAT "THE ADAPTER OPENING OF THE MASK IS DEFECTIVE AND AS THE PLASTIC IS MORE RIGID THAN IT USED TO BE." NO OTHER DETAILS WERE PROVIDED AND NO PATIENT INJURY/HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    843185 AIRFLOW RESUS BAG BTM VENTLAB LLC. AFW1140MB 309894

    Patients

    Seq Age Sex Outcome Treatment
    1