BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HT70 PLUS VENTILATOR W/O2 MONITOR

    MDR report key: 3900394 · Received May 6, 2014

    Report

    Report Number
    2023050-2014-00184
    Event Type
    Malfunction
    Date Received
    May 6, 2014
    Date of Event
    April 9, 2014
    Report Date
    April 10, 2014
    Manufacturer
    NEWPORT MEDICAL INSTRUMENTS, INC.
    Product Code
    CBK
    PMA / PMN Number
    K090888
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO COVIDIEN, AND THE COVIDIEN CUSTOMER SUPPORT ENGINEER (CSE) VERIFIED THE MALFUNCTION. THE CSE INSPECTED THE DEVICE AND REPLACED THE OXYGEN SENSOR. THE CSE ALSO PERFORMED THE 12 MONTH PREVENTIVE MAINTENANCE (PM) AND REPLACED THE FAN FILTER AND INLET FILTER PER THE PM. THE CSE UPGRADED THE SOFTWARE. THE UNIT PASSED ALL TESTS AND CALIBRATIONS. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE OXYGEN SENSOR ON THE HT70 PLUS VENTILATOR PROVIDED ERRATIC READINGS. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271971 HT70 PLUS VENTILATOR W/O2 MONITOR CBK, NOU CBK NEWPORT MEDICAL INSTRUMENTS, INC. HT70

    Patients

    Seq Age Sex Outcome Treatment
    1