BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESUS BAG ADULT MANUAL 6/CS

    MDR report key: 2862028 · Received December 7, 2012

    Report

    Report Number
    8030673-2012-00249
    Event Type
    Malfunction
    Date Received
    December 7, 2012
    Date of Event
    October 17, 2012
    Report Date
    November 30, 2012
    Manufacturer
    CAREFUSION
    Product Code
    BTM
    PMA / PMN Number
    K924610
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: NO SAMPLE WAS RETURNED FOR EVALUATION. THEREFORE THE REPORTED CONDITION COULD NOT BE CONFIRMED AND A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. THE LOT NUMBER WAS NOT PROVIDED THEREFORE A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED. A TREND REVIEW WAS CONDUCTED AND FOUND THAT NO SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. OUR MANUFACTURING PROCESS WAS REVIEWED AND WE COULDN'T FIND ANYTHING THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. ADDITIONALLY, NO ISSUES WERE FOUND WITH THE MATERIALS OR DESIGN. AT THIS TIME NO CORRECTIVE ACTION WILL BE APPLIED.

    Additional Manufacturer Narrative · 1

    (B)(4). CORRECTION: THE PREVIOUS FOLLOW-UP MEDWATCH WAS INADVERTENTLY SUBMITTED WITHOUT A MFR RECEIVED DATE. THE MFR RECEIVED DATE FOR THE PREVIOUSLY SUBMITTED MEDWATCH IS 2/12/2013.

    Additional Manufacturer Narrative · 1

    (B)(4). SAMPLE WAS DISCARDED. UPON COMPLETION OF OUR INVESTIGATION, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    VIA MAUDE EVENT REPORT.  "WHAT WE FOUND WAS THAT WHERE THE OXYGEN TUBING WAS CONNECTED TO THE BACK OF THE BAG VALVE MASK, AN ACUTE BEND WAS MADE AND CONCEALED BY THE OXYGEN RESERVOIR. APPARENTLY THIS BEND LED TO A KINK AND OCCLUSION OF THE OXYGEN LINE, HENCE NO OXYGEN FLOW TO THE MASK AT 15 L/MIN. A SECOND SYSTEM WAS INSPECTED AND FOUND THE SAME THING. IM NOT SURE IF ITS DUE TO JUST THE KINKING, OR WHETHER THE TUBING IS SOFT ENOUGH TO PARTIALLY FUSE IN POSITION. I ALSO DON'T KNOW IF THERE ARE TEMPERATURE SPECIFICATIONS FOR THIS DEVICE THAT MAY HAVE BEEN EXCEEDED IN AMBULANCE STORAGE. EITHER WAY, IT LED TO REAL LIFE INABILITY TO DELIVER OXYGEN ABOVE ROOM AIR LEVELS FOR A PT. WHO NEEDED IMMEDIATE INTUBATION ON ARRIVAL TO THE EMERGENCY DEPARTMENT. I HAVE LEARNED THAT THE AMBULANCES HAVE NO AIR CONDITIONING, SO THE TEMPERATURE CAN GET QUITE HIGH, WHICH MAY HAVE HAD AN IMPACT ON THE PRODUCT. INVESTIGATION RESULTS: COMPLAINT REPORT ASSOCIATED NSN (B)(4) WITH CAREFUSION PART NUMBER 2K8004, BUT THEY ARE NOT EQUIVALENT DEVICES. THERE ARE TWO SOURCES FOR THIS NSN; PURITAN BENNETT P/N 133255 AND VITAL SIGNS P/N 7000A. THE CAREFUSION DEVICE WAS PROCURED THROUGH DAPA FROM CAREFUSION THROUGH CARDINAL NOT BY NSN. REPORTING ACTIVITY IS IN THE PROCESS OF SWITCHING TO AMBU DUE TO MMSEO STANDARDIZATION INITIATIVE. THE DEFECTIVE ITEM IS NOT AVAILABLE FOR INSPECTION BECAUSE THEY HAVE BEEN DISCARDED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESUS BAG ADULT MANUAL 6/CS VENTILATOR, EMERGENCY, MANUAL (RESUSCITATOR) BTM CAREFUSION 2K8004

    Patients

    Seq Age Sex Outcome Treatment
    1