BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HT70 VENTILATOR

    MDR report key: 3032686 · Received March 29, 2013

    Report

    Report Number
    2023050-2013-00251
    Event Type
    Malfunction
    Date Received
    March 29, 2013
    Date of Event
    March 7, 2013
    Report Date
    March 11, 2013
    Manufacturer
    NEWPORT MEDICAL INSTRUMENTS
    Product Code
    CBK
    PMA / PMN Number
    K090888
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    RIGHT AFTER A NEW O2 SENSOR WAS INSTALLED, FIO2 VALUE CONSTANTLY INDICATED DIFFERENT FROM THE ACTUAL VALUE. THEN AN 'O2 SENSOR ERROR' OCCURRED. CALIBRATING THE O2 SENSOR COULD NOT SOLVE THE ISSUE. THIS ISSUE WAS RESOLVED THE REPLACING THE O2 SENSOR. THIS COMPLAINT WAS SUBMITTED AS OUT OF BOX. THERE WAS NO PATIENT INVOLVEMENT IN THIS CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    130364 HT70 VENTILATOR CBK, NOU CBK NEWPORT MEDICAL INSTRUMENTS HT70

    Patients

    Seq Age Sex Outcome Treatment
    1