BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYPERBARIC VENTILATOR

    MDR report key: 6415444 · Received March 17, 2017

    Report

    Report Number
    2020676-2017-00004
    Event Type
    Malfunction
    Date Received
    March 17, 2017
    Date of Event
    February 26, 2017
    Report Date
    February 27, 2017
    Manufacturer
    SECHRIST INDUSTRIES, INC.
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS NOT BEEN RETURNED FOR AN EVALUATION. SHOULD THE PRODUCT BE RETURNED OR NEW INFORMATION IS MADE AVAILABLE, A FOLLOW UP REPORT WILL BE PROVIDED. STILL PENDING PRODUCT RETURN.

    Additional Manufacturer Narrative · 1

    THE UNIT WAS RETURNED AND TESTED PER DOCUMENTS 170186 REV. 8 AND 150094 REV. 7. DURING THE FIRST PART OF THE TEST DURING THE PRESSURIZATION OF THE LEAK TEST THE UNIT BECAME STUCK IN SUSTAINED INSPIRATORY PHASE. THE TEST WAS ABORTED DUE TO THE POSSIBLE DAMAGE TO THE TEST EQUIPMENT, AND NO FURTHER TESTING WAS DONE. UPON FURTHER EXAMINATION THE FLUIDIC INTERFACE VALVE WAS STUCK AND BLEEDING GAS FROM THE PORT, IT NORMALLY CYCLES ON AND OFF. ROOT CAUSE: THE UNIT HAS NOT BEEN OVERHAULED; OVERHAUL DUE (B)(6) 2015. SECHRIST OVERHAULED THE UNIT, REPLACING ALL RUBBER AND PLASTIC PARTS, REBUILT, ADJUSTED AND CALIBRATED TO FACTORY SPECIFICATIONS. A DEVICE HISTORY REVIEW (DHR) WAS PERFORMED. HV-500A VENTILATOR SERIAL NUMBER (B)(4) WAS MANUFACTURED ON 10/01/2009. THERE IS NO INDICATION THAT THERE WERE ANY RELEVANT DISCREPANCIES DURING MANUFACTURING. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOUND NO NON-CONFORMANCE THAT COULD CAUSE OR CONTRIBUTE TO THE REPORTED ISSUE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING CLINICAL USE OF HYPERBARIC VENTILATOR TECHNICIAN NOTICED THAT THE PATIENT WAS NOT EXHALING AND THE 2 INDICATORS ON THE VENT WERE GREEN. TECHNICIAN TURNED THE VENT OFF SO THE PATIENT COULD EXHALE AND THEN STARTED MANUAL VENTILATION WHILE DEPRESSURIZING THE CHAMBER. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    196124 HYPERBARIC VENTILATOR VENTILATOR, CONTINUOUS CBK SECHRIST INDUSTRIES, INC. HV-500A

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR