BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    840 VENTILATOR

    MDR report key: 6999494 · Received November 3, 2017

    Report

    Report Number
    8020893-2017-07766
    Event Type
    Malfunction
    Date Received
    November 3, 2017
    Report Date
    January 17, 2018
    Manufacturer
    COVIDIEN
    Product Code
    CBK
    PMA / PMN Number
    K970460
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) REPLACED THE PIEZO ALARM. DURING SERVICING FOUND A DIAGNOSTIC CODE IN MEMORY AND REPLACED THE GUI CPU (GRAPHICAL USER INTERFACE, CENTRAL PROCESSING UNIT). THE FSE PERFORMED TESTING AND CALIBRATIONS AND THE VENTILATOR OPERATED WITHIN MANUFACTURING SPECIFICATIONS. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    A GRAPHIC USER INTERFACE (GUI) PRINTED CIRCUIT BOARD (PCB) 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 AND FUNCTIONALITY TESTING WAS PERFORMED, NO ERRORS WERE FOUND 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: A PIEZO ALARM 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; ERRORS WERE FOUND IN THE DIAGNOSTIC LOGS AND FUNCTIONALITY TESTING WAS PERFORMED. AN INVESTIGATION WAS PERFORMED AND THE PRODUCT ANALYSIS TECHNICIAN REPORTED THAT THE ROOT CAUSE WAS ISOLATED TO AN ELECTRONIC COMPONENT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE 840 VENTILATOR DID NOT GENERATE AN AUDIBLE ALARM DURING TESTING. THE VENTILATOR WAS NOT IN USE ON A PATIENT AT THE TIME OF THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    781139 840 VENTILATOR VENTILATOR, CONTINUOUS, FACILITY USE CBK COVIDIEN 840

    Patients

    Seq Age Sex Outcome Treatment
    1