BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HT70 VENTILATOR

    MDR report key: 3001620 · Received March 11, 2013

    Report

    Report Number
    2023050-2013-00166
    Event Type
    Injury
    Date Received
    March 11, 2013
    Date of Event
    December 4, 2013
    Report Date
    February 18, 2013
    Manufacturer
    NEWPORT MEDICAL INSTRUMENTS
    Product Code
    CBK
    PMA / PMN Number
    K090888
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THOUGH REQUESTED, ADDITIONAL PATIENT INFORMATION WAS NOT PROVIDED.

    Description of Event or Problem · 1

    REPORTEDLY, DURING PATIENT USE, THE SILENCE LED FLASHED SIMULTANEOUSLY BUT THERE WAS NO ALARM. THE UNIT SHUT DOWN WITHOUT ANY ALARM AND THE PATIENT WAS AMBU BAGGED BEFORE BEING SWITCHED TO ANOTHER VENTILATOR. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    101649 HT70 VENTILATOR CBK, NOU CBK NEWPORT MEDICAL INSTRUMENTS HT70

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention