BEUDAMED
    FDA Adverse Event Death Summary report: N

    HT70 PLUS VENTILATOR

    MDR report key: 3590897 · Received January 8, 2014

    Report

    Report Number
    2023050-2014-00002
    Event Type
    Death
    Date Received
    January 8, 2014
    Date of Event
    January 1, 2013
    Report Date
    December 19, 2013
    Manufacturer
    NEWPORT MEDICAL INSTRUMENTS, INC.
    Product Code
    CBK
    PMA / PMN Number
    K111146
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    REPORTEDLY, DURING PATIENT USE, A BATTERY FAILURE OCCURRED. THE PATIENT REPORTEDLY DIED. THE CAUSE OF THE PATIENT'S DEATH HAS NOT BEEN VERIFIED TO BE RELATED TO ANY DEVICE MALFUNCTION. NO FURTHER INFORMATION WAS AVAILABLE. THE INVESTIGATION OF THE DEVICE IS IN PROGRESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    14837 HT70 PLUS VENTILATOR CBK, NOU CBK NEWPORT MEDICAL INSTRUMENTS, INC. HT70PM

    Patients

    Seq Age Sex Outcome Treatment
    1 Death