BEUDAMED
    FDA Adverse Event Death Summary report: N

    SUNMED VENTLAB PEEP VALVE

    MDR report key: 8922997 · Received August 21, 2019

    Report

    Report Number
    MW5089263
    Event Type
    Death
    Date Received
    August 21, 2019
    Date of Event
    August 1, 2019
    Report Date
    August 5, 2019
    Manufacturer
    VENT LAB LLC / SUNMED HOLDINGS, LLC
    Product Code
    BYE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A (B)(6) Y/O FEMALE, GUN SHOT TO FACE AND HIP. TEMPORARY USE OF VENTLAB PEEP VALVE MALFUNCTIONED AT MAX LEVEL. REMOVED PEEP VALVE USED ANOTHER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    712850 SUNMED VENTLAB PEEP VALVE ATTACHMENT, BREATHING, POSITIVE END EXPIRATORY PRESSURE BYE VENT LAB LLC / SUNMED HOLDINGS, LLC VP703 318781

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Death