BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HT70 VENTILATOR

    MDR report key: 3872325 · Received April 18, 2014

    Report

    Report Number
    2023050-2014-00150
    Event Type
    Malfunction
    Date Received
    April 18, 2014
    Report Date
    March 20, 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
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS EXPECTED TO BE RECEIVED FOR EVAL. A SUPPLEMENTAL REPORT WILL BE SUBMITTED SHOULD THE DEVICE BECOME AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED FROM THE USA WITH INFO STATING THE TOUCH SCREEN WAS FOUND TO BE UNRESPONSIVE. THE DEVICE WAS NOT REPORTED TO HAVE BEEN IN USE ON A PT AT THE TIME OF THIS EVENT. THE DATE OF THE EVENT WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    238494 HT70 VENTILATOR CBK, NOU CBK NEWPORT MEDICAL INSTRUMENTS, INC. HT70M

    Patients

    Seq Age Sex Outcome Treatment
    1