BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEWPORT MEDICAL INSTRUMENTS, INC.

    MDR report key: 6515863 · Received April 24, 2017

    Report

    Report Number
    2023050-2017-05207
    Event Type
    Malfunction
    Date Received
    April 24, 2017
    Date of Event
    March 22, 2017
    Report Date
    March 27, 2017
    Manufacturer
    NEWPORT MEDICAL INSTRUMENTS, INC.
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A MALFUNCTION OF THE BATTERY. THE CUSTOMER REPORTED THE BATTERY WAS ALREADY DISCHARGED. THE CUSTOMER DID NOT PROVIDE DEVICE INFORMATION. THERE WAS NO PATIENT INVOLVEMENT. REPAIR WILL BE COMPLETED AT A NON-MEDTRONIC LOCATION AND THE PRODUCT IS NOT IN MEDTRONIC CONTROL. THE REPORTED COMPLAINT COULD NOT BE CONFIRMED WITHOUT THE PRODUCT RETURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    298420 NEWPORT MEDICAL INSTRUMENTS, INC. VENTILATOR, CONTINUOUS, FACILITY USE CBK NEWPORT MEDICAL INSTRUMENTS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1