BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEWPORT MEDICAL INSTRUMENTS,INC.

    MDR report key: 5033601 · Received August 26, 2015

    Report

    Report Number
    2023050-2015-00178
    Event Type
    Injury
    Date Received
    August 26, 2015
    Report Date
    August 4, 2015
    Manufacturer
    NEWPORT MEDICAL INSTRUMENTS, INC.
    Product Code
    CBK
    PMA / PMN Number
    K082724
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PATIENT USE, THE VENTILATOR GAVE "MORE THAN 30 OF THE MAXIMUM INTERNAL PRESSURE". THE PATIENT WAS TRANSFERRED TO ANOTHER VENTILATOR WITHOUT ANY REPORTED HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    565706 NEWPORT MEDICAL INSTRUMENTS,INC. CONTINUOUS VENTILATOR CBK NEWPORT MEDICAL INSTRUMENTS, INC. HT50

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention