BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYPERBARIC VENTILATOR

    MDR report key: 2894605 · Received December 27, 2012

    Report

    Report Number
    2020676-2012-00053
    Event Type
    Malfunction
    Date Received
    December 27, 2012
    Date of Event
    November 26, 2012
    Report Date
    December 27, 2012
    Manufacturer
    SECHRIST INDUSTRIES, INC.
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS CURRENTLY UNDER EVALUATION BY THE MFR. A FOLLOW-UP SUBMISSION WILL BE PROVIDED UPON COMPLETION OF THE EVALUATION.

    Description of Event or Problem · 1

    THE HYPERBARIC VENTILATOR IS STUCK IN SUSTAINED INSPIRATORY MODE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HYPERBARIC VENTILATOR VENTILATOR, CONTINUOUS, FACILITY USE CBK SECHRIST INDUSTRIES, INC. 3000

    Patients

    Seq Age Sex Outcome Treatment
    1