BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HT70 PLUS VENTILATOR

    MDR report key: 5033053 · Received August 26, 2015

    Report

    Report Number
    2023050-2015-00175
    Event Type
    Injury
    Date Received
    August 26, 2015
    Date of Event
    July 29, 2015
    Report Date
    August 6, 2015
    Manufacturer
    NEWPORT MEDICAL INSTRUMENTS, INC
    Product Code
    CBK
    PMA / PMN Number
    K111146
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, THE PATIENT HAD BEEN USING A HAMILTON C2 VENTILATOR AND STARTED USING A HT70 WITH THE SAME SETTINGS. THE HT70'S SATURATION OF PERIPHERAL OXYGEN (SPO2) VALUES DIDN'T CHANGE, BUT THE CO2 VALUE ROSE FROM 60 TO 90. ALTHOUGH THE DEVICE CONTINUED VENTILATING, THE PATIENT WAS TRANSFERRED BACK TO THE HAMILTON C2 VENTILATOR. THE CO2 VALUE THEN DECLINED TO 60. THERE WAS NO REPORT OF SERIOUS INJURY OR DEATH ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    563914 HT70 PLUS VENTILATOR CONTINUOUS VENTILATOR CBK NEWPORT MEDICAL INSTRUMENTS, INC HT70 PLUS

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention