BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HT70 VENTILATOR

    MDR report key: 2850563 · Received November 27, 2012

    Report

    Report Number
    2023050-2012-00307
    Event Type
    Malfunction
    Date Received
    November 27, 2012
    Date of Event
    September 15, 2012
    Report Date
    November 1, 2012
    Manufacturer
    NEWPORT MEDICAL INSTRUMENTS, INC.
    Product Code
    CBK
    PMA / PMN Number
    K090888
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    DURING TESTING, O2 SENSOR WAS NON-FUNCTIONAL. THERE WAS NO PATIENT INVOLVEMENT IN THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1