BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HT70 VENTILATOR

    MDR report key: 3050250 · Received April 5, 2013

    Report

    Report Number
    2023050-2013-00276
    Event Type
    Malfunction
    Date Received
    April 5, 2013
    Date of Event
    December 3, 2012
    Report Date
    April 4, 2013
    Manufacturer
    NEWPORT MEDICAL INSTRUMENT
    Product Code
    CBK
    PMA / PMN Number
    K090888
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED VENTILATOR WAS VISUALLY INSPECTED AND NO ANOMALIES WERE FOUND. DURING THE FUNCTIONAL TEST, THE FIO2 SUPPLY MEASURED WAS DIFFERENT FROM THE FIO2 SETTING, CONFIRMING THE REPORTED ISSUE. THE INVESTIGATION CONCLUDED THAT THE RETURNED OXYGEN SENSOR WAS DEFECTIVE. A DESIGN CHANGE WAS INTRODUCED IN ORDER TO STABILIZE AND IMPROVE THE ACCURACY OF FIO2 DELIVERY.

    Description of Event or Problem · 1

    REPORTEDLY, THE VENTILATOR HAD PROBLEMS WITH VOLUME DELIVERY. IT WAS ALSO REPORTED THAT THE ALARM COULD NOT BE ADJUSTED. THERE WAS NO PT INVOLVEMENT REPORTED. INVESTIGATION OF THE UNIT FOUND THAT THE OXYGEN SENSOR WAS DEFECTIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    141732 HT70 VENTILATOR CBK, NOU CBK NEWPORT MEDICAL INSTRUMENT HT70

    Patients

    Seq Age Sex Outcome Treatment
    1