BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HT50 VENTILATOR

    MDR report key: 4221268 · Received November 3, 2014

    Report

    Report Number
    2023050-2014-00456
    Event Type
    Injury
    Date Received
    November 3, 2014
    Date of Event
    October 2, 2014
    Report Date
    October 10, 2014
    Manufacturer
    NEWPORT MEDICAL INSTRUMENTS
    Product Code
    CBK
    PMA / PMN Number
    K082724
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HOSPITAL SERVICE TECHNICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN ENGINEER VISITED AND PERFORMED THE EXHALATION VALVE CALIBRATION WHICH FAILED TWICE. THE CUSTOMER COMPLAINT OF THE DIFFERENCE IN VOLUME READING FROM THE VENTILATOR TO ACTUAL MEASURED VOLUME WAS CONFIRMED. THE INVESTIGATION IS ONGOING. (B)(4).

    Additional Manufacturer Narrative · 1

    A COVIDIEN INVESTIGATION VERIFIED THE COMPLAINT. THE INVESTIGATOR INSTALLED THE RETURNED PUMP INTO AN HT50 TEST VENTILATOR AND THERE WAS AN UNUSUAL VIBRATING NOISE. THIS NOISE WAS TRACED BACK TO AN INTAKE VALVE INTERNAL TO THE PUMP. THE HT50 PUMP ASSEMBLY WAS REPLACED. (B)(4).

    Description of Event or Problem · 1

    COVIDIEN RECEIVED INFORMATION STATING THAT DURING PATIENT USE, THE" ACTUAL VENTILATION VOLUME ON AN HT50 VENTILATOR WAS PHYSICALLY INCREASED". A STRANGE NOISE FROM THE VENTILATOR WAS CONFIRMED BUT IT STOPPED AND THE DEVICE CONTINUED TO BE USED. ABOUT SIX HOURS LATER, THE PATIENT WAS PLACED ON ANOTHER DEVICE. THE H50 UNIT WAS THEN CONNECTED TO A TEST LUNG AND A 'HIGH MV' (MV = MINUTE VENTILATION) ALARM WAS GENERATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    701752 HT50 VENTILATOR CONTINUOUS VENTILATOR CBK NEWPORT MEDICAL INSTRUMENTS HT50

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention