BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HT70 PLUS VENTILATOR

    MDR report key: 3012549 · Received March 15, 2013

    Report

    Report Number
    2023050-2013-00176
    Event Type
    Injury
    Date Received
    March 15, 2013
    Date of Event
    February 24, 2013
    Report Date
    February 25, 2013
    Manufacturer
    NEWPORT MEDICAL INSTRUMENTS
    Product Code
    CBK
    PMA / PMN Number
    K111146
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THOUGH REQUESTED, ADDITIONAL PATIENT INFORMATION WAS NOT PROVIDED.

    Description of Event or Problem · 1

    REPORTEDLY, DURING PATIENT USE, WHILE VENTILATING IN SIMV MODE, THE VENTILATOR CHANGED TO SPONTANEOUS MODE. THE PATIENT WAS SEDATED A T THE TIME AND HAD NO SPONTANEOUS RESPIRATIONS. THE PATIENT WAS MANUALLY VENTILATED AND TRANSFERRED TO ANOTHER VENTILATOR. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    110846 HT70 PLUS VENTILATOR CBK, NOU CBK NEWPORT MEDICAL INSTRUMENTS HT70PM

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention