BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEWPORT MEDICAL INSTRUMENTS, INC.

    MDR report key: 5170357 · Received October 23, 2015

    Report

    Report Number
    2023050-2015-00278
    Event Type
    Injury
    Date Received
    October 23, 2015
    Date of Event
    September 18, 2015
    Report Date
    December 21, 2017
    Manufacturer
    NEWPORT MEDICAL INSTRUMENTS, INC.
    Product Code
    CBK
    PMA / PMN Number
    K090888
    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

    COVIDIEN REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS REPAIRED AND THE REPORTED ISSUE WAS ISOLATED TO A MECHANICAL PROBLEM. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PATIENT USE ON A HOMECARE PATIENT, THE VENTILATOR GENERATED A SYSTEM ERROR ALARM. VENTILATION STOPPED AND THE DEVICE WAS INOPERATIVE. IT WAS FORCIBLY TURNED OFF. THE PATIENT WAS REMOVED FROM THE VENTILATOR AND TRANSFERRED TO ANOTHER VENTILATOR WITHOUT ANY REPORTED HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    701560 NEWPORT MEDICAL INSTRUMENTS, INC. CONTINUOUS VENTILATOR CBK NEWPORT MEDICAL INSTRUMENTS, INC. HT70

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention