BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEWPORT

    MDR report key: 6570473 · Received May 16, 2017

    Report

    Report Number
    2023050-2017-05293
    Event Type
    Malfunction
    Date Received
    May 16, 2017
    Date of Event
    April 12, 2017
    Report Date
    April 18, 2017
    Manufacturer
    NEWPORT MEDICAL INSTRUMENTS, INC.
    Product Code
    CBK
    PMA / PMN Number
    K0980888
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    A SINGLE BOARD COMPUTER (SBC) WAS RETURNED TO COVIDIEN/MEDTRONIC¿S PRODUCT ANALYSIS. THE SBC WAS INSTALLED INTO A TEST VENTILATOR FOR ANALYSIS. AN INVESTIGATION WAS PERFORMED AND THE PRODUCT ANALYSIS TECHNICIAN REPORTED THAT THE REPORTED ISSUE VERIFIED. THE ROOT CAUSE WAS ISOLATED TO SOFTWARE. CORRECTION PMA/510K#: K090888. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO USE THE HT70 VENTILATOR HAD SCREEN FROZE AT PHOTO IMAGE UPON POWERING ON. THERE WAS NO PATIENT INVOLVEMENT REPORTED. MEDTRONIC WAS NOT AUTHORIZED TO EVALUATE/SERVICE THE DEVICE SO THE REPORTED COMPLAINT COULD NOT BE CONFIRMED. A NON-MEDTRONIC SERVICE PROVIDER STATED THAT THE CONDITION WAS REPLACED AND NORMAL OPERATION WAS CONFIRMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349976 NEWPORT VENTILATOR, CONTINUOUS, FACILITY USE CBK NEWPORT MEDICAL INSTRUMENTS, INC. HT70

    Patients

    Seq Age Sex Outcome Treatment
    1