BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    980 VENTILATOR

    MDR report key: 5641518 · Received May 9, 2016

    Report

    Report Number
    8020893-2016-01071
    Event Type
    Malfunction
    Date Received
    May 9, 2016
    Report Date
    December 7, 2017
    Manufacturer
    COVIDIEN
    Product Code
    CBK
    PMA / PMN Number
    K131252
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COVIDIEN SERVICE ENGINEER (SE) INSPECTED THE DEVICE AND WAS NOT ABLE TO DUPLICATE THE ALLEGED MALFUNCTION. THE SE RELOADED THE CURRENT SOFTWARE AND PERFORMED EXTENDED SELF-TESTING ON THE DEVICE AND ALL TESTS PASSED.

    Additional Manufacturer Narrative · 1

    A BREATH DELIVERY (BD) PRINTED CIRCUIT BOARD (PCB) WAS RETURNED TO COVIDIEN/MEDTRONIC¿S PRODUCT ANALYSIS. A VISUAL INSPECTION OF THE RETURNED COMPONENT WAS PERFORMED, NO NOTABLE CONDITIONS WERE FOUND. THE RETURNED COMPONENT WERE INSTALLED INTO A TEST VENTILATOR FOR ANALYSIS; NO ERRORS WERE RECORDED IN THE DIAGNOSTIC LOGS. AN INVESTIGATION WAS PERFORMED AND THE PRODUCT ANALYSIS TECHNICIAN REPORTED THAT NO FAULT WAS FOUND. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS: AN EXHALATION VALVE MODULE (EVM) ASSEMBLY WAS RETURNED TO COVIDIEN/ MEDTRONIC¿S PRODUCT ANALYSIS. THE RETURNED COMPONENT WAS INSTALLED INTO A TEST VENTILATOR FOR ANALYSIS AND FUNCTIONAL 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. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, WHEN TURNED ON A 980 VENTILATOR GENERATED AN INOPERABLE DIAGNOSTIC CODE. THE VENTILATOR WAS NOT IN USE ON A PATIENT AT THE TIME THE MALFUNCTION OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    295428 980 VENTILATOR CONTINUOUS VENTILATOR CBK COVIDIEN 980

    Patients

    Seq Age Sex Outcome Treatment
    1