BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESUS, ADLT W/MASK, 40" TBG, 6/CS

    MDR report key: 5936203 · Received September 8, 2016

    Report

    Report Number
    8030673-2016-00223
    Event Type
    Injury
    Date Received
    September 8, 2016
    Date of Event
    August 15, 2016
    Report Date
    November 30, 2016
    Manufacturer
    CAREFUSION/BD
    Product Code
    OEV
    PMA / PMN Number
    ENFORCEMENT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION SUMMARY: ELEVEN SAMPLES WERE RECEIVED FOR EVALUATION. THE SAMPLES WERE FUNCTIONALLY AND VISUALLY INSPECTED AND NO ISSUES WERE FOUND RELATED TO THE CUSTOMERS REPORT; THEREFORE THE FAILURE MODE COULD NOT BE CONFIRMED. THE DEVICE HISTORY RECORD WAS REVIEWED FOR THE REPORTED LOT NUMBER, AND FOR THE REPRESENTATIVE SAMPLE LOT NUMBERS. NO ISSUES RELATED TO THE REPORTED FAILURE MODE WERE FOUND. THE PRODUCT WAS MANUFACTURED, INSPECTED, AND RELEASED IN ACCORDANCE WITH CAREFUSION/BD INTERNAL PROCEDURES. CAREFUSION/BD DID EVALUATE SIMILAR COMPLAINTS BASED ON TREND; A PROBABLE ROOT CAUSE CAN BE ASSOCIATED, EVEN THOUGH THE FAILURE MODE WAS NOT PRESENT IN THE PROVIDED SAMPLE. THE PROBABLE ROOT CAUSE FOR THE REPORTED FAILURE MODE COULD BE RELATED TO THE CURRENT MIRROR FINISH SURFACE ON THE ELBOW. THIS COULD MAKE THE MASK VERY DIFFICULT TO REMOVE. A NEW BRUSHED SURFACE FINISH HAS BEEN VALIDATED TO ELIMINATE THIS TYPE OF FAILURE. CAREFUSION/BD HAS ALSO RETRAINED THE ASSEMBLY PERSONNEL ON THE ASSEMBLY METHOD BETWEEN THE ELBOW AND THE MASK TO ENSURE A CORRECT PRESS FIT AS AN IMMEDIATE CONTAINMENT ACTION. A CORRECTIVE AND PREVENTATIVE ACTION HAS ALSO BEEN OPENED ON THIS REPORTED FAILURE TO FURTHER INVESTIGATE THE ROOT CAUSE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING A CODE BLUE, A BAG/MASK WAS USED ON THE PATIENT. AFTER INTUBATING THE PATIENT THEY TRIED TO REMOVE THE MASK TO RESUSCITATE PATIENT AND THEY WERE UNABLE TO REMOVE THE MASK. THEY WERE ABLE TO FIND A DEVICE TO RESUSCITATE THE PATIENT AND THERE WAS NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    588644 RESUS, ADLT W/MASK, 40" TBG, 6/CS MANUAL EMERGENCY VENTILATOR OEV CAREFUSION/BD 0000933584

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention