BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HT70 VENTILATOR

    MDR report key: 3822884 · Received February 5, 2014

    Report

    Report Number
    2023050-2014-00034
    Event Type
    Malfunction
    Date Received
    February 5, 2014
    Date of Event
    December 12, 2013
    Report Date
    December 24, 2013
    Manufacturer
    NEWPORT MEDICAL INSTRUMENTS, INC.
    Product Code
    CBK
    PMA / PMN Number
    K090888
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER HAD THE COIN BATTERY REPLACED, WHICH RESOLVED THE REPORTED ISSUE. FURTHER EVAL WILL BE PERFORMED AS REQUIRED.

    Description of Event or Problem · 1

    REPORTEDLY, DURING TESTING, AFTER BOOTING UP THE VENTILATOR, THE TOUCH PANEL DID NOT WORK. THE DEVICE WAS NOT IN USE ON A PT WHEN THIS EVENT OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    76359 HT70 VENTILATOR CBK, NOU CBK NEWPORT MEDICAL INSTRUMENTS, INC. HT70M

    Patients

    Seq Age Sex Outcome Treatment
    1