BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYPERBARIC VENTILATOR

    MDR report key: 5877711 · Received August 15, 2016

    Report

    Report Number
    2020676-2016-00007
    Event Type
    Malfunction
    Date Received
    August 15, 2016
    Date of Event
    April 11, 2016
    Report Date
    April 11, 2016
    Manufacturer
    SECHRIST INDUSTRIES, INC.
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED UNIT WAS RETURNED FOR EVALUATION. THE UNIT WAS TESTED PER DOCUMENTS 170186 REV. 8 AND 150094 REV. 6. THE UNIT FUNCTIONED WITHIN SPECIFICATIONS. AFTER THE INITIAL TEST WAS DONE ON THE UNIT IT WAS OPENED AND EXAMINED, ONE OF THE TUBES GOING TO THE MASTER VALVE IS SPLIT AND THE MANUAL BREATH BUTTON HAS A SMALL LEAK ON THE BOTTOM. THE SPLIT ON THE TUBING MAY BE DUE TO A SMALL NICK AT THE EDGE OF THE TUBE AND OVER TIME THE NICK DEVELOPED INTO A SPLIT. THE LEAK ON THE MANUAL BREATH BUTTON VALVE IS DUE TO THE AGE OF THE PART. THE UNIT HAS BEEN REPAIRED AND WILL BE SHIPPED TO CUSTOMER. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOUND NO NONCONFORMANCE THAT COULD CAUSE OR CONTRIBUTE TO THE REPORTED ISSUE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VENTILATOR HAS AN AIR LEAK. NO PATIENT INVOLVEMENT OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    528338 HYPERBARIC VENTILATOR VENTILATOR CBK SECHRIST INDUSTRIES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1