BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 5936183 · Received September 8, 2016

    Report

    Report Number
    8030673-2016-00222
    Event Type
    Injury
    Date Received
    September 8, 2016
    Date of Event
    August 11, 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
    MA, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Additional Manufacturer Narrative · 1

    CAREFUSION HAS REACHED OUT TO CUSTOMER TO PROVIDE THE COMPLAINT DEVICE FOR FURTHER INVESTIGATION. IT HAS BEEN CONFIRMED THAT THE DEVICE IS NOT AVAILABLE FOR INVESTIGATION. IF WE RECEIVE ANY ADDITIONAL INFORMATION WE WILL PROVIDE A FOLLOW UP EMDR. (B)(4).

    Additional Manufacturer Narrative · 1

    UNFORTUNATELY THE SAMPLE USED DURING THIS REPORTED INCIDENT WAS NOT AVAILABLE FOR EVALUATION IT WAS DISPOSED OF BY THE END-USER; THEREFORE THE FAILURE MODE COULD NOT BE CONFIRMED AT THIS TIME. THE LOT NUMBER WAS ALSO UNAVAILABLE; CAREFUSION/BD COULD NOT EVALUATE THE DEVICE HISTORY RECORD FOR ANY FURTHER INFORMATION. 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 THE MASKS ARE DIFFICULT TO REMOVE FROM THE MANUAL RESUSCITATORS. THE CUSTOMER STATED, "IN A TRAUMA EVENT YESTERDAY IT TOOK 3 DIFFERENT PEOPLE TO GET THE MASK OFF, AND BY THE TIME THEY DID THEY HAD ALREADY OPENED ANOTHER BAG." THE CUSTOMER REPORTED THAT THERE WAS NO PATIENT HARM OR INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    587015 RESUS, ADLT W/MASK, 40" TBG, 6/CS MANUAL EMERGENCY VENTILATOR OEV CAREFUSION/BD

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention