BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYPERBARIC VENTILATOR

    MDR report key: 5948183 · Received September 13, 2016

    Report

    Report Number
    2020676-2016-00010
    Event Type
    Malfunction
    Date Received
    September 13, 2016
    Date of Event
    August 1, 2016
    Report Date
    August 15, 2016
    Manufacturer
    SECHRIST INDUSTRIES, INC.
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED UNIT WAS RETURNED ON 09/01/2016 AND IS PENDING EVALUATION.

    Additional Manufacturer Narrative · 1

    THE UNIT WAS TESTED PER DOCUMENTS 170186 REV. 8 AND 150094 REV. 7, WHEN THE GAS SUPPLY WAS TURNED ON THE UNIT STARTED TO CYCLE AND COULD NOT BE SHUT OFF. THE COMPLAINT IS VERIFIED. EVALUATION: THE MASTER VALVE COULD NOT BE SHUT OFF WHEN TURNED, TESTING WAS COMPLETED ALL OTHER FUNCTIONS WERE FOUND TO BE WITHIN SPECIFICATION. ROOT CAUSE: THE MASTER KNOB CAN BE HARD TO TURN CAUSING STRAIN ON THE SET SCREW IN THE COUPLING ASSEMBLY, OVER TIME THE SET SCREW HAS WORKED LOOSE AND IS SLIPPING ON THE SHAFT. THIS REPORT IS SUBMITTED TO COMPLY WITH MDR MALFUNCTION NOTICE 76 FR 12473 REQUIRING THE REPORTING OF INCIDENTS INVOLVING A LIFE-SUPPORTING AND/OR LIFE-SUSTAINING DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER SHUTTING OFF THE UNIT IT WAS STILL OSCILLATING. NO PATIENT INVOLVEMENT OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    599893 HYPERBARIC VENTILATOR VENTILATOR, PRODUCT CODE: CBK CBK SECHRIST INDUSTRIES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1