BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    980 VENTILATOR

    MDR report key: 6728020 · Received July 20, 2017

    Report

    Report Number
    8020893-2017-07031
    Event Type
    Malfunction
    Date Received
    July 20, 2017
    Report Date
    December 4, 2017
    Manufacturer
    COVIDIEN
    Product Code
    CBK
    PMA / PMN Number
    K131252
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS: A COMPRESSOR DIRECT CURRENT (DC) POWER SUPPLY AND A COMPRESSOR POWER DISTRIBUTION PRINTED CIRCUIT BOARD (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 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. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A 980 VENTILATOR GENERATE A COMPRESSOR FAULT DIAGNOSTIC MESSAGE. THE VENTILATOR WAS NOT IN USE ON A PATIENT AT THE TIME OF THE REPORTED EVENT. AS A GOOD FAITH MEASURE, THE SERVICE ENGINEER (SE) REPLACED THE COMPRESSOR POWER SUPPLY, COMPRESSOR DISTRIBUTION PRINTED CIRCUIT BOARD (PCBA), COMPRESSOR CONTROLLER PCBA, AND COMPRESSOR INTERFACE PCBA. THE SE PERFORMED CALIBRATIONS AND EXTENDED SELF-TESTING ON THE DEVICE AND ALL TESTS PASSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    510580 980 VENTILATOR VENTILATOR, CONTINUOUS, FACILITY USE CBK COVIDIEN 980

    Patients

    Seq Age Sex Outcome Treatment
    1