BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    980 VENTILATOR

    MDR report key: 5998834 · Received October 4, 2016

    Report

    Report Number
    8020893-2016-02624
    Event Type
    Malfunction
    Date Received
    October 4, 2016
    Report Date
    December 8, 2017
    Manufacturer
    COVIDIEN
    Product Code
    CBK
    PMA / PMN Number
    K131252
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COVIDIEN SERVICE ENGINEER (SE) INSPECTED THE DEVICE AND VERIFIED THE REPORTED ISSUE. THE SE REPLACED THE LINE INTERFACE PRINTED CIRCUIT BOARD (PCB). THE SE PERFORMED EXTENDED SELF-TESTING ON THE DEVICE AND ALL TESTS PASSED.

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS: A LINE INTERFACE 2 PRINTED CIRCUIT BOARD (PCB) AND A FLASH DRIVE WERE RETURNED TO COVIDIEN/ MEDTRONIC¿S PRODUCT ANALYSIS. A VISUAL INSPECTION OF THE RETURNED COMPONENTS WAS PERFORMED, NO NOTABLE CONDITIONS WERE FOUND. THE RETURNED COMPONENTS WERE INSTALLED INTO A TEST VENTILATOR FOR ANALYSIS AND FUNCTIONALITY TESTING WAS PERFORMED, NO ERRORS WERE RECORDED IN THE DIAGNOSTIC LOGS. AN INVESTIGATION WAS PERFORMED AND THE PRODUCT ANALYSIS TECHNICIAN REPORTED THAT NO FAULT WAS FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, ON START UP A 980 VENTILATOR GENERATED A SERIAL NUMBER MISMATCH DIAGNOSTIC MESSAGE. THE VENTILATOR WAS NOT IN USE ON A PATIENT AT THE TIME THE EVENT OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    649425 980 VENTILATOR CONTINUOUS VENTILATOR CBK COVIDIEN 980

    Patients

    Seq Age Sex Outcome Treatment
    1