BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    500A HYPERBARIC VENTILATOR

    MDR report key: 8476592 · Received April 2, 2019

    Report

    Report Number
    2020676-2019-00004
    Event Type
    Malfunction
    Date Received
    April 2, 2019
    Date of Event
    March 8, 2019
    Report Date
    March 8, 2019
    Manufacturer
    SECHRIST INDUSTRIES, INC.
    Product Code
    CBK
    PMA / PMN Number
    K760852
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    QA EVALUATION OF THE DEVICE OBSERVED THAT THE DEVICE WOULD BE STUCK ON EXHALATION WHEN THE EXHALATION VALVE KNOB WAS SET TO MAXIMUM TIMING. THE EXHALATION VALVE WAS DISASSEMBLED AND IT WAS FOUND THAT THE SETSCREWS FOR THE KNOB TO HOLD ONTO THE EXHALATION VALVE PIN WERE WORN. IT IS PROBABLE THE SETSCREWS LOST GRIP OF THE VALVE PIN, ITS CALIBRATION, AND WAS RESET WITH THE EXHALATION VALVE PIN FULLY TWISTED IN, CAUSING THE HBO VENT TO BE STUCK IN EXHALATION SETTING. THE SETSCREWS WERE REPLACED WITH NEW SETSCREWS. THE EXHALATION VALVE WAS RECALIBRATED PER FACTORY SPECIFICATIONS. THE DEVICE WAS TESTED AND OBSERVED FOR ANY PERSISTENT FINDINGS. AFTER EXTENSIVE TESTING, THE REPORTED PROBLEM WAS NO LONGER FOUND AND NO ADDITIONAL FINDINGS WERE OBSERVED DURING TESTING. DEVICE HISTORY RECORD REVIEW FOUND: HBO VENT MODEL HV 500A S.N. (B)(4) WAS MANUFACTURED ON (B)(6) 1996, WHICH INDICATES THAT THE HBO VENTILATOR HAS BEEN IN SERVICE FOR OVER 23 YEARS. 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. REVIEW OF THE SERVICE HISTORY RECORD SHOWS THE DEVICE WAS LAST SERVICED BY SECHRIST ON (B)(6) 2017, UNDER RA2017-30140. THERE WERE NO DISCREPANCIES RECORDED DURING FUNCTIONAL TESTING BY MANUFACTURING OR QUALITY CONTROL THAT COULD CAUSE OR CONTRIBUTE TO THE REPORTED ISSUE. BOTH MANUFACTURING AND QUALITY CONTROL RECORDED ALL VALUES WITHIN SPECIFICATION. MANUFACTURER REFERENCES FILE # (B)(4).

    Description of Event or Problem · 0

    SUPPLEMENTAL REPORT REQUIRED FOR PRODUCT EVALUATION.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS CURRENTLY UNDERWAY. ONCE COMPLETE A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    AT REGULAR SCHEDULED TESTING OF THE VENTILATOR, IT WAS FOUND THAT DURING EXHALATION TIME, UNIT CONTINUES TO AUTO CYCLE AND WHEN TURNED TO THE MAXIMUM (SHOULD BE 5 SECONDS), IT STOPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    266601 500A HYPERBARIC VENTILATOR VENTILATOR CBK SECHRIST INDUSTRIES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1