BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTLAB

    MDR report key: 7013292 · Received November 9, 2017

    Report

    Report Number
    2246980-2017-00029
    Event Type
    Malfunction
    Date Received
    November 9, 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

    THE CUSTOMER DID NOT RETURN THE AFFECTED DEVICE TO BE EVALUATED AND NO LOT NUMBER WAS PROVIDED. A NONCONFORMANCE HAS BEEN OPENED TO FURTHER INVESTIGATE THE CUSTOMER CLAIMS.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGES THAT "MASK WILL NOT CONNECT TO THE RESUS BAG. " NO OTHER DETAILS WERE PROVIDED AND NO PATIENT INJURY/HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    792546 VENTLAB RESUS BAG BTM VENTLAB LLC. CPRM1116M

    Patients

    Seq Age Sex Outcome Treatment
    1