BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HT70 VENTILATOR

    MDR report key: 2833530 · Received October 29, 2012

    Report

    Report Number
    2023050-2012-00235
    Event Type
    Malfunction
    Date Received
    October 29, 2012
    Date of Event
    September 26, 2012
    Report Date
    October 3, 2012
    Manufacturer
    NEWPORT MEDICAL INSTRUMENTS
    Product Code
    CBK
    PMA / PMN Number
    K090888
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE RETURNED VENTILATOR WAS VISUALLY INSPECTED AND NO ANOMALIES WERE NOTED. THE VENTILATOR WAS POWERED ON USING BOTH A BATTERY SOURCE AND A POWER SOURCE; IT FUNCTIONED NORMALLY. A CIRCUIT CHECK TEST WAS PERFORMED AND THE UNIT PASSED. THE OXYGEN SENSOR WAS TESTED AND THE REPORTED FIO2 ISSUE WAS DUPLICATED. THE OXYGEN SENSOR WAS CONFIRMED TO HAVE CAUSED THE REPORTED ISSUE.

    Description of Event or Problem · 1

    REPORTEDLY, DURING TESTING, IT WAS FOUND THAT THE FIO2 ON THE VENTILATOR WAS NOT WORKING. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HT70 VENTILATOR CBK, NOU CBK NEWPORT MEDICAL INSTRUMENTS HT70

    Patients

    Seq Age Sex Outcome Treatment
    1