BEUDAMED
    FDA Adverse Event Death Summary report: N

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

    MDR report key: 7049414 · Received November 21, 2017

    Report

    Report Number
    8030673-2017-00384
    Event Type
    Death
    Date Received
    November 21, 2017
    Date of Event
    November 6, 2017
    Report Date
    December 12, 2017
    Manufacturer
    VYAIRE MEDICAL, INC
    Product Code
    OEV
    PMA / PMN Number
    ENFORCEMENT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY AWAITING FOR THE SAMPLE. ONCE THE INVESTIGATION IS COMPLETE A FOLLOW UP SUBMISSION WILL BE FILED.

    Additional Manufacturer Narrative · 1

    ONE OPEN SAMPLE WAS RECEIVED FOR EVALUATION. AFTER PERFORMING A VISUAL INSPECTION TO THE AFFECTED SAMPLE IT WAS OBSERVED THAT THE TUBE WAS DETACHED FROM THE THREADED O2 HOUSING. BOTH COMPONENTS SHOWED A POOR EVIDENCE OF SOLVENT. IT IS CONSIDERED THAT ASSEMBLY PERSONNEL ARE RELATED TO THE DISCONNECTION OF THE RESUSCITATOR BY APPLYING AN INADEQUATE AMOUNT OF THE SOLVENT ON THE UNION BETWEEN THE PVC TUBING AND THE HOUSING FOR A COMPLETE ASSEMBLY OF THE PRODUCT. SINCE THE DEFECT WAS PROVOKED DUE TO A LACK OF SOLVENT, PERSONNEL WERE RE-TRAINED AND NOTIFIED ABOUT THIS ISSUE.

    Description of Event or Problem · 1

    MD WAS ATTEMPTING A STAT INTUBATION IN ED. THE AMBU BAG WITH MASK WAS ATTACHED TO WALL O2 AT 15 L/ 100%. AS THE MD ATTEMPTED TO USE THE BAG WITH MASK ON THE PATIENT PRIOR TO INTUBATION, THE INTERNAL O2 TUBING DISCONNECTED FROM THE BAG. THE O2 TUBING WAS NOT ABLE TO BE RECONNECTED TO THE BAG. THE PATIENT PRESENTED TO THE TRAUMA BAY OF THE ED AND NEEDED EMERGENCY INTUBATION DUE TO THEIR STATUS. THE CLINICIANS WERE BAGGING THE PATIENT AND NOTICED THEY WERE UNABLE TO STABILIZE THE PATIENT AS THE PATIENT WAS DESATURATING AND HYPOTENSIVE. WHILE BAGGING THE PATIENT, THE CLINICIAN NOTICED THAT THE OXYGEN TUBING HAD BECOME DISCONNECTED FROM THE RESUSCITATIVE DEVICE AND WAS UNABLE TO BE REINSERTED TO CONTINUE BAGGING. ANOTHER DEVICE WAS GRABBED AND WAS SUCCESSFUL AT VENTILATING THE PATIENT. THE PATIENT WAS EASILY INTUBATED AND VENTILATED. HOWEVER, LATER IN THE COURSE OF THE STAY AT ED, THE PATIENT ENDED UP CRASHING AND CODING AND EVENTUALLY EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    828343 RESUS, ADLT W/MASK, 40" TBG, 6/CS CARDIOPULMONARY RESUSCITATION AID KIT OEV VYAIRE MEDICAL, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| R