BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HT70 VENTILATOR

    MDR report key: 2770030 · Received September 28, 2012

    Report

    Report Number
    2023050-2012-00190
    Event Type
    Malfunction
    Date Received
    September 28, 2012
    Date of Event
    August 31, 2012
    Report Date
    September 3, 2012
    Manufacturer
    NEWPORT MEEDICAL INSTRUMENT
    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

    DURING REPAIR, AN 'O2 SENSOR' ALARM OCCURRED. REPLACING THE O2 SENSOR RESOLVED THE ISSUE. NO PT INVOLVEMENT IN THIS CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HT70 VENTILATOR CBK, NOU CBK NEWPORT MEEDICAL INSTRUMENT HT70

    Patients

    Seq Age Sex Outcome Treatment
    1