BEUDAMED
    FDA Adverse Event Death Summary report: N

    RESUS,ADLT,MSK,TUBE RSV,PEEP,MANO,7' TBG

    MDR report key: 5825926 · Received July 27, 2016

    Report

    Report Number
    8030673-2016-00158
    Event Type
    Death
    Date Received
    July 27, 2016
    Date of Event
    September 21, 2015
    Report Date
    September 28, 2015
    Manufacturer
    CAREFUSION/BD
    Product Code
    OEV
    PMA / PMN Number
    ENFORCEMENT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) SAMPLE EVALUATION SUMMARY: ONE OPEN SAMPLE WAS RECEIVED IT WAS EVALUATED ACCORDING TO OUR INSPECTION PROCEDURE AND DID NOT PRESENT ANY VISUAL PROBLEMS. IN ADDITIONAL THE SAMPLE WAS SUBMITTED FOR A DIMENSIONAL INSPECTION, AND NO PROBLEMS WERE FOUND. THE DEVICE HISTORY RECORD FOR THE LOT REPORTED WAS EVALUATED FOR ANY ISSUES RELATED WITH THIS CUSTOMER REPORT. THE PRODUCT WAS MANUFACTURED, INSPECTED AND RELEASED IN ACCORDANCE WITH OUR INTERNAL PROCEDURES AND NO ISSUES WERE OBSERVED. TWO YEARS OF COMPLAINTS WERE REVIEWED FROM DECEMBER 1, 2013 - NOVEMBER 30, 2015 AND NO TREND WAS OBSERVED. SINCE THE ISSUE REPORTED CANNOT BE CONFIRMED (THE SAMPLE DOES NOT PRESENT ANY ANOMALIES) IT IS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE OF THE ISSUE REPORTED. NO CORRECTIVE ACTION WILL BE IMPLEMENTED SINCE THE FAILURE REPORTED WAS NOT CONFIRMED DURING SAMPLE EVALUATION. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER STATED THAT THE MASK WILL NOT COME OFF THE ELBOW. WHEN THE THERAPIST WENT TO REMOVE THE MASK TO CONTINUE TO VENTILATE THE PATIENT AFTER INTUBATION, THE MASK WOULD NOT COME OFF. A NEW RESUSCITATION BAG WAS OBTAINED. THE PATIENT CAME IN THE EMERGENCY ROOM WITH CPR BEING PERFORMED. THE PATIENT DID REGAIN A HEART RATE AND WAS INTUBATED BUT PASSED AWAY SHORTLY AFTER INTUBATING. CUSTOMER CONFIRMED THAT THE PATIENT'S DEATH WAS NOT DUE TO PRODUCT FAILURE. "WE WERE UNSUCCESSFUL AT MAINTAINING A HEART RATE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    478486 RESUS,ADLT,MSK,TUBE RSV,PEEP,MANO,7' TBG CARDIOPULMONARY RESUSCITATION AID KIT OEV CAREFUSION/BD 2K8035M 0000785469

    Patients

    Seq Age Sex Outcome Treatment
    1 Death