BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HT70 VENTILATOR

    MDR report key: 3894154 · Received February 6, 2014

    Report

    Report Number
    2023050-2014-00044
    Event Type
    Malfunction
    Date Received
    February 6, 2014
    Date of Event
    December 25, 2013
    Report Date
    January 8, 2014
    Manufacturer
    NEWPORT MEDICAL INSTRUMENTS, INC.
    Product Code
    CBK
    PMA / PMN Number
    K0908888
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    COVIDIEN RECEIVED INFORMATION THAT DURING TESTING, THE VENTILATOR DISPLAY DID NOT BOOT UP AND A WHITE SCREEN WAS DISPLAYED. THE DEVICE WAS NOT IN USE ON A PATIENT WHEN THIS EVENT OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78407 HT70 VENTILATOR CBK, NOU CBK NEWPORT MEDICAL INSTRUMENTS, INC. HT70M

    Patients

    Seq Age Sex Outcome Treatment
    1