BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 5936230 · Received September 8, 2016

    Report

    Report Number
    8030673-2016-00224
    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

    CAREFUSION HAS REACHED OUT TO CUSTOMER TO PROVIDE THE COMPLAINT DEVICE FOR FURTHER INVESTIGATION. THE SAMPLE WAS RECEIVED IN A CAREFUSION GENERAL OFFICE AND FORWARDED TO THE CAREFUSION MANUFACTURING FACILITY FOR FURTHER EVALUATION. ONCE AN EVALUATION IS COMPLETED THEN A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION SUMMARY: ONE SAMPLE WAS RECEIVED FOR FURTHER EVALUATION. THE UNIT WAS SUBMITTED TO A FUNCTIONAL INSPECTION, AND NO ISSUES RELATED TO THE CUSTOMERS REPORT WERE FOUND; THEREFORE THE FAILURE MODE WAS NOT CONFIRMED. THE DEVICE HISTORY RECORD WAS REVIEWED FOR THE REPORTED LOT NUMBER AND 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 WHILE TRYING TO RESUSCITATE AN INTUBATED PATIENT, THE MASK ON THE BAG WOULD NOT COME OFF THE BAG AND THEY WERE UNABLE TO RESUSCITATE THE PATIENT USING THE AFFECTED PRODUCT. THE CUSTOMER STATED THEY USED ANOTHER RESUSCITATOR WITH LITTLE DELAY. IT WAS CONFIRMED THAT THERE WAS NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    587578 RESUS, ADLT W/MASK, 40" TBG, 6/CS MANUAL EMERGENCY VENTILATOR OEV CAREFUSION/BD

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention