BEUDAMED
    FDA Adverse Event Summary report: N

    ADAPTER HUMIDIFIER 120/CS

    MDR report key: 3023432 · Received March 27, 2013

    Report

    Report Number
    8030673-2013-00035
    Date Received
    March 27, 2013
    Date of Event
    March 5, 2013
    Report Date
    March 8, 2013
    Manufacturer
    CAREFUSION
    Product Code
    BTT
    PMA / PMN Number
    K801252
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE IS IN THE PROCESS OF BEING SENT TO THE MANUFACTURING PLANT. UPON COMPLETION OF CAREFUSION'S INVESTIGATION, A FOLLOW UP MEDWATCH WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY:A REPRESENTATIVE SAMPLE WAS RECEIVED FOR EVALUATION. THE SAMPLE WAS VISUALLY INSPECTED AND NO ISSUES WERE OBSERVED. A REVIEW OF THE PRODUCTION RECORD WAS PERFORMED AND NO ISSUES WERE DISCOVERED. IN ADDITION, NO SIMILAR COMPLAINTS HAVE BEEN REPORTED. PER OUR MANUFACTURING PROCEDURE, THIS PRODUCT IS 100% QUALITY INSPECTED. AT THIS TIME, IT'S NOT POSSIBLE DETERMINE A ROOT CAUSE FOR THIS INCIDENT AS THE EVALUATED SAMPLE WAS NOT FOUND TO BE DEFECTIVE. ADDITIONALLY, NO CORRECTIVE ACTION WILL BE IMPLEMENTED SINCE THE FAILURE REPORTED WAS NOT CONFIRMED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED:THE PATIENT WAS GIVEN OXYGEN VIA A MASK. OXYGEN WAS GIVEN CONTINUOUSLY, HOWEVER, THERE WAS A DECREASE IN THE O2 SATURATION. A CLOSE LOOK IDENTIFIED, THAT THE ADAPTER WAS LEAKING, AND O2 COULD PASS AWAY. SOMETHING WAS BROKEN INSIDE THE SCREW OF THE WHITE CONNECTOR SO THE STAFF CHANGED DEVICE. NO PATIENT INJURY. ONE UNOPENED REPRESENTATIVE SAMPLE FROM THE SAME LOT WILL BE SENT TO THE MANUFACTURING PLANT FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126753 ADAPTER HUMIDIFIER 120/CS HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE) BTT CAREFUSION ALP2002 0000374019

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention