BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESQPOD

    MDR report key: 2238401 · Received August 24, 2011

    Report

    Report Number
    3003477173-2011-00001
    Event Type
    Malfunction
    Date Received
    August 24, 2011
    Date of Event
    July 11, 2011
    Report Date
    August 24, 2011
    Manufacturer
    ADVANCED CIRCULATORY SYSTEMS, INC.
    Product Code
    BWF
    PMA / PMN Number
    K033401
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    EVENT DESC: PT INTUBATED DURING CPR. DEVICE ATTACHED TO ET TUBE. DEVICE HAD A LEAK, RESULTING IN NO CHEST RISE. AIR WAS COMING OUT FROM THE DEVICE. SECOND DEVICE WAS ATTACHED WHICH WORKED WITHOUT PROBLEM. WHAT WAS THE ORIGINAL INTENDED PROCEDURE: VENTILATION VIA INTUBATION AND RESPIRATOR. DEVICE USAGE PROBLEM: DEVICE FAILED (E.G. BROKE, COULDN'T GET IT TO WORK OR STOPPED WORKING).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESQPOD BWF ADVANCED CIRCULATORY SYSTEMS, INC. 7753569

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other