BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HT70 VENTILATOR

    MDR report key: 3912228 · Received May 13, 2014

    Report

    Report Number
    2023050-2014-00186
    Event Type
    Malfunction
    Date Received
    May 13, 2014
    Date of Event
    April 15, 2014
    Report Date
    May 8, 2014
    Manufacturer
    NEWPORT MEDICAL INSTRUMENTS, INC.
    Product Code
    CBK
    PMA / PMN Number
    K090888
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION REGARDING THIS REPORT HAS NOT BEEN PROVIDED. (B)(4).

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED FROM THE USA STATING THAT AN HT70 VENTILATOR EXPERIENCED A MALFUNCTION. THE CUSTOMER STATED THAT THE OXYGEN SENSOR DID NOT CALIBRATE. THERE WERE NO REPORTED PATIENT INVOLVEMENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    285623 HT70 VENTILATOR CBK NEWPORT MEDICAL INSTRUMENTS, INC. HT70

    Patients

    Seq Age Sex Outcome Treatment
    1