BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYPERBARIC VENTILATOR

    MDR report key: 6348164 · Received February 21, 2017

    Report

    Report Number
    2020676-2017-00001
    Event Type
    Malfunction
    Date Received
    February 21, 2017
    Date of Event
    February 2, 2017
    Report Date
    February 2, 2017
    Manufacturer
    SECHRIST INDUSTRIES, INC.
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED UNIT WAS RETURNED FOR AN EVALUATION. THE UNIT WAS INSPECTED PER DOCUMENTS 150094 REV.7 AND 170186 REV. 8 TESTING WAS NOT COMPLETED DUE TO THE FLOW KNOB COMING LOOSE. THE COMPLAINT WAS VERIFIED. SECHRIST TECHNICIAN TIGHTENED FLOW VOLUMN KNOB AND TESTED UNIT TO MEET FACTORY SPECIFICATIONS. UNIT REPAIRED AND RETURNED TO CUSTOMER. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED. VENTILATOR MODEL 3000, SERIAL NUMBER (B)(4), WAS MANUFACTURED ON (B)(6) 2012. 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. 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.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED FOR AN EVALUATION. SHOULD NEW INFORMATION BECOME AVAILABLE SECHRIST WILL SUBMIT AN EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PRE-CLINICAL CHECK OF HBO VENTILATOR THE VENTILATOR DID NOT REACH MAXIMUM EXPIRATORY TIME. NO PATIENT INVOLVEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    129241 HYPERBARIC VENTILATOR VENTILATOR, CONTINUOUS, FACILITY USE CBK SECHRIST INDUSTRIES, INC. HV-500A

    Patients

    Seq Age Sex Outcome Treatment
    1