BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIO-MED DEVICES, INC.

    MDR report key: 10257188 · Received July 10, 2020

    Report

    Report Number
    10257188
    Event Type
    Malfunction
    Date Received
    July 10, 2020
    Date of Event
    December 26, 2019
    Report Date
    January 14, 2020
    Manufacturer
    BIO-MED DEVICES, INC.
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE ISSUE WITH THE MANOMETER NOT READING ANY CPAP PRESSURE WHEN BABY WAS ON IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    723658 BIO-MED DEVICES, INC. VENTILATOR, CONTINUOUS, FACILITY USE CBK BIO-MED DEVICES, INC. CROSSVENT

    Patients

    Seq Age Sex Outcome Treatment
    1 365 DA Other