BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    840 VENTILATOR

    MDR report key: 4101868 · Received August 25, 2014

    Report

    Report Number
    8020893-2014-02105
    Event Type
    Malfunction
    Date Received
    August 25, 2014
    Date of Event
    August 14, 2014
    Report Date
    August 14, 2014
    Manufacturer
    COVIDIEN
    Product Code
    CBK
    PMA / PMN Number
    K970460
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COVIDIEN CUSTOMER SUPPORT ENGINEER (CSE) INSPECTED THE DEVICE AND VERIFIED THE MALFUNCTION. THE CSE REPLACED THE POWER SUPPLY AND PERFORMED EXTENDED SELF-TESTING ON THE DEVICE AND ALL TESTS PASSED. (B)(4).

    Additional Manufacturer Narrative · 1

    THE COVIDIEN FIELD SERVICE SUPPORT ENGINEER (FSSE) RECEIVED A TAMURA (TAIYO YUDEN) POWER SUPPLY REPORTED AS ¿SMOKE WAS COMING OUT OF THE POWER SUPPLY¿. A VISUAL INSPECTION OF THE RETURNED UNIT WAS CONDUCTED, AND NO ANOMALIES WERE OBSERVED. FUNCTIONALITY TESTS WERE PERFORMED ON A TEST VENTILATOR, AND SUCCESSFULLY RUNNING ALL TESTS AS DETAILED IN THE 840 VENTILATOR SERVICE MANUAL. THE UNIT WAS ATTACHED TO THE FAILURE INVESTIGATION TEST VENTILATOR AND POWERED UP. THE UNIT POWERED UP NORMALLY WITH NO ERRORS RECORDED IN THE DIAGNOSTIC LOGS. CALIBRATIONS PROCEDURES WERE RUN SUCCESSFULLY WITHOUT ANY ERRORS. THE UNIT WAS PUT INTO NORMAL VENTILATION MODE, AND SUCCESSFULLY RAN FOR FIVE HOURS. A REVIEW OF THE VENTILATOR DIAGNOSTIC LOGS REVEALED NO ERRORS AND NO UNEXPECTED ALARMS WERE OBSERVED DURING THIS PERIOD. INTERNAL VISUAL EXAMINATION OF THE UNIT REVEALED SEVERE THERMAL DAMAGE OF THE C5 CAPACITOR ON PRINTED CIRCUIT BOARD (PCB) C01. THE CAPACITOR WAS EXPOSED TO AN OVERVOLTAGE CONDITION. THE APPROPRIATE AUDIO AND VISUAL ALARMS WOULD ENUNCIATE. IF NO BPS WAS INSTALLED AN INDEPENDENT ALARM WOULD SOUND FOR AT LEAST TWO MINUTES. THE CUSTOMER REPORTED MALFUNCTION WAS VERIFIED.

    Description of Event or Problem · 1

    COVIDIEN RECEIVED INFO STATING THAT SMOKE WAS COMING OUT OF THE POWER SUPPLY OF AN 840 VENTILATOR. THE VENTILATOR WAS NOT IN USE ON A PT AT THE TIME THE MALFUNCTION OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    510950 840 VENTILATOR CONTINUOUS VENTILATOR CBK COVIDIEN 840

    Patients

    Seq Age Sex Outcome Treatment
    1