BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HT70 VENTILATOR

    MDR report key: 2842161 · Received November 15, 2012

    Report

    Report Number
    2023050-2012-00279
    Event Type
    Injury
    Date Received
    November 15, 2012
    Date of Event
    October 24, 2012
    Report Date
    October 24, 2012
    Manufacturer
    NEWPORT MEDICAL INSTRUMENTS
    Product Code
    CBK
    PMA / PMN Number
    K090888
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: THE RETURNED VENTILATOR WAS VISUALLY INSPECTED AND NO ANOMALIES WERE NOTED. THE VENTILATOR WAS POWERED ON AN ALLOWED TO RUN; THE AIR PUMP GENERATED AND UNUSUAL NOISE. THE HOUSING COVER WAS REMOVED AND DEBRIS WAS OBSERVED TO BE PRESENT ON.

    Description of Event or Problem · 1

    REPORTEDLY, DURING PT USE, THERE WAS AN UNUSUAL NOISE GENERATED FROM THE VENTILATOR. THE PT WAS MANUALLY VENTILATED AND SWITCHED TO ANOTHER VENTILATOR. THE VOLUME WAS LOW WHEN IT WAS MEASURED BY AN EXTERNAL GAUGE. THE NOISE WOULD INCREASE WHEN THE PEEP VOLUME WAS SET. THERE WERE NO ADVERSE PT EFFECTS REPORTED.

    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 Required Intervention