BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    980 VENTILATOR

    MDR report key: 6896006 · Received September 26, 2017

    Report

    Report Number
    8020893-2017-07711
    Event Type
    Malfunction
    Date Received
    September 26, 2017
    Date of Event
    September 7, 2017
    Report Date
    February 19, 2018
    Manufacturer
    COVIDIEN
    Product Code
    CBK
    PMA / PMN Number
    K131252
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS: A MIX CONTROLLER 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 WAS INSTALLED INTO A TEST VENTILATOR FOR ANALYSIS; NO ERRORS WERE FOUND IN THE DIAGNOSTIC LOGS AND FUNCTIONALITY TESTING WAS PERFORMED. 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

    COVIDIEN/MEDTRONIC HAS NOT RECEIVED THE DEVICE/COMPONENT FROM THE CUSTOMER FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, WHILE IN USE ON A PATIENT, A 980 VENTILATOR STOPPED VENTILATION AND AN ERROR MESSAGE WAS FOUND IN THE LOG. THERE WAS NO PATIENT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    673923 980 VENTILATOR VENTILATOR, CONTINUOUS, FACILITY USE CBK COVIDIEN 980

    Patients

    Seq Age Sex Outcome Treatment
    1