BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 7075339 · Received December 1, 2017

    Report

    Report Number
    8030673-2017-00391
    Event Type
    Injury
    Date Received
    December 1, 2017
    Date of Event
    October 11, 2017
    Report Date
    December 1, 2017
    Manufacturer
    VYAIRE MEDICAL, INC
    Product Code
    OEV
    PMA / PMN Number
    ENFORCEMENT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT HAS BEEN CONFIRMED BY THE MEDWATCH THAT THE COMPLAINT SAMPLE IS NOT AVAILABLE FOR EVALUATION. AN ATTEMPT HAS BEEN MADE BY VYAIRE TO GAIN ADDITIONAL INFORMATION AND A REPRESENTATIVE SAMPLE FROM THE SAME LOT NUMBER FROM THE CUSTOMER. VYAIRE IS STILL WAITING FOR ADDITIONAL INFORMATION REGARDING REPORTED ISSUE. IF A SAMPLE OR ANY ADDITIONAL INFORMATION BECOMES AVAILABLE AFTER ALL DUE DILIGENCE ATTEMPTS HAVE BEEN COMPLETED A FOLLOW UP EMDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    PER MEDWATCH REPORT (B)(4). COULD NOT FEEL OR HEAR OXYGEN THROUGH BAG/VALVE MASK. ATTEMPTED TO USE BAG/VALVE MASK ON PATIENT AND EVEN WITH GOOD SEAL AND CHEST RISE THE PATIENTS O2 SATS WOULD NOT IMPROVE, NOTICED THAT WE COULD NOT FEEL THE OXYGEN FLOW OR HEAR IT THROUGH THE BAG/VALVE MASK. THIS OCCURRED DURING GENERAL ANESTHESIA FOR REPAIR OF A LEFT POPLITEAL ARTERY. HOSPITAL PROVIDED PATIENT IDENTIFIER (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    856157 RESUS, ADLT W/MASK, 40" TBG, 6/CS CARDIOPULMONARY RESUSCITATION AID KIT OEV VYAIRE MEDICAL, INC 001086128

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention