BEUDAMED
    FDA Adverse Event Summary report: N

    THE BAG II DISPOSABLE RESUSCITATOR

    MDR report key: 3872095 · Received May 29, 2014

    Report

    Report Number
    9610483-2014-00001
    Date Received
    May 29, 2014
    Date of Event
    January 1, 2014
    Report Date
    May 14, 2014
    Manufacturer
    LAERDAL MEDICAL A.S.
    Product Code
    BTM
    PMA / PMN Number
    K021716
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE BAG II RESUSCITATOR DFU STATES FOR HIGH OXYGEN CONCENTRATIONS, CONNECT OXYGEN TUBING AND RESERVOIR TO RESUSCITATOR. ADJUST THE O2 FLOW TO ENSURE THE RESERVOIR REMAINS FULLY OR PARTIALLY INFLATED DURING USE. FOR GREATER THAN 90% OXYGEN CONCENTRATIONS THE OXYGEN FLOW MUST BE AT LEAST 3 LITERS/MINUTE FOR THE ADULT MODEL. A FOLLOW-UP EMAIL TO THE INITIAL REPORTER CONFIRMED THE RESUSCITATOR FUNCTIONED PROPERLY AND THE CAUSE OF THE OXYGEN LEAK WAS NOT KNOWN.

    Description of Event or Problem · 1

    LAERDAL MEDICAL A.S. (LMAS) IN (B)(4) HAS INFORMED LAERDAL MEDICAL CORP. (LMC) IN (B)(4) OF AN EVENT WHICH OCCURRED IN (B)(6) (EVENT DATE AND PT DETAILS NOT PROVIDED). FOLLOWING A CARDIAC ARREST, A THE BAG II RESUSCITATOR WAS USED TO VENTILATE A NON-BREATHING PT AND CONNECT THEM TO PORTABLE OXYGEN. THE 2 LITER O2 TANK WAS QUICKLY EMPTIED. PT WAS INTUBATED AND THE BAG II RESUSCITATOR WAS USED TO VENTILATE THEM. OXYGEN FROM THE AMBULANCE WAS CONNECTED TO THE RESUSCITATOR AT 15 L/MIN FLOW AND THE BAG II RESUSCITATOR'S OXYGEN RESERVOIR WAS ONLY SLIGHTLY INFLATED. THE PT REGAINED SPONTANEOUS BREATHING WHILE IN THE AMBULANCE. THE PT'S FINAL OUTCOME IS UNK. THE BAG II RESUSCITATOR MAY HAVE BEEN LEAKING OXYGEN. THE INVOLVED RESUSCITATOR WAS DISPOSED OF BY THE HEALTHCARE FACILITY AND NOT AVAILABLE FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    316794 THE BAG II DISPOSABLE RESUSCITATOR MANUAL DISPOSABLE RESUSCITATOR BTM LAERDAL MEDICAL A.S. 240613

    Patients

    Seq Age Sex Outcome Treatment
    1