BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HT70 VENTILATOR

    MDR report key: 3050249 · Received April 5, 2013

    Report

    Report Number
    2023050-2013-00277
    Event Type
    Malfunction
    Date Received
    April 5, 2013
    Date of Event
    September 10, 2012
    Report Date
    April 5, 2013
    Manufacturer
    NEWPORT MEDICAL INSTRUMENTS, INC.
    Product Code
    CBK
    PMA / PMN Number
    K090888
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE RETURNED OXYGEN SENSOR WAS VISUALLY INSPECTED AND NO ANOMALIES WERE FOUND. DURING THE FUNCTIONAL TEST, THE FIO2 SUPPLY MEASURED WAS DIFFERENT FROM THE FIO2 SETTING. THE INVESTIGATION CONCLUDED THAT THE OXYGEN SENSOR WAS DEFECTIVE. THE UNIT WILL BE RETURNED AFTER REPLACING THE OXYGEN SENSOR.

    Description of Event or Problem · 1

    DURING INVESTIGATING THE RETURNED VENTILATOR WITH THE REPORTED ISSUE WITH FAILED OXYGEN ANALYZER, IT WAS NEWLY FOUND THAT THE OXYGEN SENSOR WAS FAULTY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    139832 HT70 VENTILATOR CBK, NOU CBK NEWPORT MEDICAL INSTRUMENTS, INC. HT70

    Patients

    Seq Age Sex Outcome Treatment
    1