BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYPERBARIC VENTILATOR

    MDR report key: 2971114 · Received February 1, 2013

    Report

    Report Number
    2020676-2013-00001
    Event Type
    Malfunction
    Date Received
    February 1, 2013
    Date of Event
    January 4, 2013
    Report Date
    February 1, 2013
    Manufacturer
    SECHRIST INDUSTRIES, INC.
    Product Code
    CBF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED FAILURE WAS VERIFIED AND DUPLICATED. EVALUATION OF THE DEVICE TOOK PLACE BY THE MANUFACTURER. THE EXHALATION KNOB TURNS PAST THE STOP DUE TO THE KNOB BEING SET AT THE INCORRECT HEIGHT. THIS ALLOWED THE KNOB TO SLIP PAST THE STOP PIN. FURTHER TESTING FOUND THAT THE MAXIMUM INHALATION AND EXHALATION TIMES AND THE MINIMUM INHALATION TIME WERE OUT OF SPECIFICATION. THE TIDAL VOLUME AT 1000 IS OUT OF SPECIFICATION AT 2.0ATA, 2.5ATA AND 3.0ATA. THE IMMEDIATE CAUSE OF THE INHALATION AND EXHALATION TIMES AND TIDAL VOLUME BEING OUT OF SPECIFICATION WAS A MALFUNCTIONING FLUIDIC INTERFACE.

    Description of Event or Problem · 1

    A BIOMEDICAL TECHNICIAN FOR THE HOSPITAL REPORTED THAT DURING A SCHEDULED PERFORMANCE MAINTENANCE TEST IT WAS FOUND THAT THE VENTILATOR PRESURE DID NOT COMPENSATE FOR THE CHAMBER PRESSURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    45292 HYPERBARIC VENTILATOR VENTILATOR, CONTINUOUS, FACILITY USE CBF SECHRIST INDUSTRIES, INC. 500A

    Patients

    Seq Age Sex Outcome Treatment
    1