BEUDAMED
    FDA Adverse Event Other Summary report: N

    PULMANEX

    MDR report key: 529413 · Received February 26, 2004

    Report

    Report Number
    1419949-2004-00004
    Event Type
    Other
    Date Received
    February 26, 2004
    Date of Event
    February 13, 2004
    Report Date
    February 24, 2004
    Manufacturer
    VIASYS MEDSYSTEMS
    Product Code
    BTM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    END USER REPORTS THAT EMERGENCY CREW ARRIVED ON SCENE TO FIND A PT IN FULL CARDIAC ARREST, WITH CPR BEING PERFORMED BY THEIR SPOUSE. THE CREW TOOK OVER CPR. WHEN THEY OPENED A NEW BAG, THEY FOUND THAT IT WAS MISSING BOTH A MASK AND THE ELBOW CONNECTOR BETWEEN THE PT VALVE AND MASK. THEY OPENED ANOTHER ONE WHICH DID HAVE A MASK, BUT NO ELBOW. THEY CONTINUED TO VENTILATE WITH A MICROSHIELD UNTIL A SECOND AMBULANCE ARRIVED WITH ANOTHER BRAND OF BAG-VALVE-MASK DEVICE. "THE END USER DOES NOT FEEL THAT THE PT'S CARE WAS COMPROMISED BY THE BAG-INCIDENT." END USER REPORTS THAT 1 OF 2 OTHER BAG UNITS IN THE TRUCK CONTAINED NO MASK AND NO CONNECTOR. THIS UNIT HAD LOT #08103001.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULMANEX MANUAL RESUSCITATOR BTM VIASYS MEDSYSTEMS NA 0810300

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR