BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIRFLOW

    MDR report key: 5999615 · Received October 5, 2016

    Report

    Report Number
    2246980-2016-00052
    Event Type
    Malfunction
    Date Received
    October 5, 2016
    Date of Event
    September 6, 2016
    Report Date
    October 5, 2016
    Manufacturer
    VENTLAB LLC.
    Product Code
    BTM
    PMA / PMN Number
    K012842
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EXTENSIVE AND THOROUGH INVESTIGATION WAS PERFORMED BY THE ENGINEERING TEAM THAT CONCLUDED THE ROOT CAUSE FOR THIS PROBLEM IS THE FACT THAT THE PATIENT PORT AND THE MASK ARE MADE OUT OF SIMILAR BASE MATERIALS RESULTING IN AN UNDESIRABLY HIGH COEFFICIENT OF FRICTION BETWEEN THE TWO PARTS. STEPS HAVE BEEN TAKEN TO IMPLEMENT A MATERIAL COMBINATION WITH A LOWER COEFFICIENT OF FRICTION THAT SIGNIFICANTLY REDUCES THE EFFORT REQUIRED TO REMOVE THE MASK FROM THE PATIENT VALVE.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGES "THE MASK COULD NOT BE REMOVED FROM THE BAG." NO OTHER DETAILS WERE PROVIDED AND NO PATIENT INJURY/HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    652667 AIRFLOW RESUS BAG BTM VENTLAB LLC. AF1100MB-MMC 305202

    Patients

    Seq Age Sex Outcome Treatment
    1