BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3000 HBO VENTILATOR

    MDR report key: 6985879 · Received October 27, 2017

    Report

    Report Number
    2020676-2017-00025
    Event Type
    Malfunction
    Date Received
    October 27, 2017
    Date of Event
    September 27, 2017
    Report Date
    October 2, 2017
    Manufacturer
    SECHRIST INDUSTRIES, INC.
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE HBO VENTILATOR WAS RETURNED BY THE CUSTOMER FOR EVALUATION AND THE REPORTED EVENT WAS VERIFIED. THE ROOT CAUSE WAS FOUND TO BE THAT THE FLOW VOLUME KNOB WAS NOT WORKING PROPERLY BECAUSE THE SET SCREWS DID NOT FULLY SECURE THE VOLUME KNOB ONTO THE SHAFT OF THE ADJUSTER. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED. 3000 HBO VENT, SERIAL NUMBER (B)(4), WAS MANUFACTURED ON 05/14/2007. THERE IS NO INDICATION THAT THERE WERE ANY RELEVANT DISCREPANCIES DURING MANUFACTURING. THIS REPORT IS SUBMITTED TO COMPLY WITH MDR MALFUNCTION NOTICE (B)(4) REQUIRING THE REPORTING OF INCIDENTS INVOLVING A LIFE-SUPPORTING AND/OR LIFE-SUSTAINING DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PRE-CLINICAL CHECK OF THE HBO VENTILATOR CUSTOMER FOUND THE FLOW VOLUME KNOB WAS NOT WORKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    762765 3000 HBO VENTILATOR HYPERBARIC VENTILATOR CBK SECHRIST INDUSTRIES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1