BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    840 VENTILATOR

    MDR report key: 6959370 · Received October 18, 2017

    Report

    Report Number
    8020893-2017-07752
    Event Type
    Malfunction
    Date Received
    October 18, 2017
    Report Date
    January 17, 2018
    Manufacturer
    COVIDIEN
    Product Code
    CBK
    UDI-DI
    10884521076983
    PMA / PMN Number
    K970460
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) REPLACED THE GUI PCB (GRAPHICAL USER INTERFACE, PRINTED CIRCUIT BOARD), THE GUI BACKLIGHT ASSEMBLY, THE GUI TOUCH FRAME AND THE CABLE. COVIDIEN/MEDTRONIC HAS NOT RECEIVED THE DEVICE/COMPONENT FROM THE CUSTOMER FOR EVALUATION.

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS: A GRAPHIC USER INTERFACE (GUI) PRINTED CIRCUIT BOARD (PCB) AND BACKLIGHT INVERTERS PCB 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; 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. 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

    PRODUCT ANALYSIS: A TOUCH FRAME PRINTED CIRCUIT BOARD (PCB) WAS RETURNED TO COVIDIEN/ MEDTRONIC¿S PRODUCT ANALYSIS. A VISUAL INSPECTION OF THE RETURNED COMPONENT WAS PERFORMED AND AREAS OF CONTAMINATION WERE FOUND IN THE PCB. THE RETURNED COMPONENT WAS INSTALLED INTO A TEST VENTILATOR FOR ANALYSIS AND FUNCTIONALITY TESTING WAS PERFORMED, NO ERRORS WERE FOUND IN THE DIAGNOSTIC LOGS. DURING EXTENDED SELF-TEST THE VENTILATOR GENERATED AN ERROR MESSAGE. AN INVESTIGATION WAS PERFORMED AND THE PRODUCT ANALYSIS TECHNICIAN REPORTED THAT ROOT CAUSE WAS ISOLATED TO THE CONTAMINATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO USE, THE 840 VENTILATOR HAD A BURNING SMELL WHEN TURNED ON. THERE WAS A PENETRATION OF LIQUID ONTO THE SCREEN. 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
    737481 840 VENTILATOR VENTILATOR, CONTINUOUS, FACILITY USE CBK COVIDIEN 840 10884521076983

    Patients

    Seq Age Sex Outcome Treatment
    1