BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIRFLOW

    MDR report key: 7121625 · Received December 15, 2017

    Report

    Report Number
    2246980-2017-00034
    Event Type
    Malfunction
    Date Received
    December 15, 2017
    Date of Event
    November 28, 2017
    Report Date
    November 28, 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

    ENGINEERING CONFIRMED THE CUSTOMER'S COMPLAINT. THE EXHALATION PORT WAS BROKEN OFF FROM THE PATIENT VALVE. WHEN REVIEWING THE FRACTURE SITE OF THE PATIENT VALVE THERE WERE STRESS MARKS ABOVE THE PORT WHERE THE FRACTURE OCCURRED LIKELY CREATED FROM PRESSURE AND/OR BLUNT FORCE APPLIED TO THE FILTER THAT IS ATTACHED TO THE EXHALATION PORT. THE CUSTOMER REPORTED THAT THEY BELIEVE THIS IS DUE TO TRANSIT. (B)(6) AGREES WITH THE CUSTOMER'S THEORY SINCE THERE WAS NO REPORTING FROM OUR CUSTOMER TO (B)(6) OF DAMAGED PRODUCT OR PACKAGING WHEN THE ORDER WAS SHIPPED FROM (B)(6) TO OUR CUSTOMER. ONLY WHEN THE PRODUCT WAS RECEIVED BY OUR CUSTOMER'S, CUSTOMER WAS THE COMPLAINT REPORTED. ENGINEERING DID PERFORM WORST CASE SCENARIO DROP TESTS TO ENSURE THAT THE PRODUCT WOULD NOT FRACTURE. TEN SAMPLE PATIENT VALVES WERE ATTACHED TO A LARGE ADULT RESUS BAG AND HELD AT A HEIGHT OF (B)(6) AND DROPPED ONTO CONCRETE FLOORING WITH THE FILTER ATTACHED TO THE EXHALATION PORT AND FACING DOWNWARD. EACH DROP PERFORMED WAS REVIEWED UNDER THE MICROSCOPE FOR ANY STRESS MARKS AT THE SAME LOCATION OF THE COMPLAINT FRACTURE. TEN DROPS WERE PERFORMED PER PATIENT VALVE SAMPLE AND NO FINDINGS WERE REPORTED. FURTHER ENGINEERING CONFIRMED THAT TRANSIT TESTING WAS PERFORMED IN THE PAST WITH A SIMILAR PRODUCT CONFIGURATION AND THERE WERE NO REPORTS OF ANY DEFECTS IDENTIFIED AFTER COMPLETION OF THE TESTING.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGES THAT " FILTER BROKE OFF THE RESUSCITATOR." NO OTHER DETAILS WERE PROVIDED AND NO PATIENT INJURY/HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    900937 AIRFLOW RESUSCITATION BAG BTM VENTLAB LLC. AF3140MB 309532

    Patients

    Seq Age Sex Outcome Treatment
    1