BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    840 VENTILATOR

    MDR report key: 4101890 · Received August 25, 2014

    Report

    Report Number
    8020893-2014-02117
    Event Type
    Malfunction
    Date Received
    August 25, 2014
    Date of Event
    August 11, 2014
    Report Date
    August 16, 2014
    Manufacturer
    COVIDIEN
    Product Code
    CBK
    PMA / PMN Number
    K970460
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COVIDIEN CUSTOMER SUPPORT ENGINEER (CSE) EVALUATED THE DEVICE, AND VERIFIED THE MALFUNCTION. THE CSE REPLACED THE KEYBOARD TO RESOLVE THE ISSUE. THE UNIT PASSED ALL TESTS AND CALIBRATIONS, AND IT WAS OBSERVED TO BE OPERATING WITHIN MANUFACTURING SPECIFICATIONS. (B)(4).

    Additional Manufacturer Narrative · 1

    COVIDIEN RECEIVED A KEYBOARD PRINTED CIRCUIT BOARD (PCB), WHICH WAS REPORTED AS HAVING A NON-OPERATIONAL RESET KEY. A VISUAL INSPECTION OF THE RETURNED KEYBOARD SHOWED NO ANOMALIES. FUNCTIONALITY WAS PERFORMED BY USING A FAILURE INVESTIGATION TEST VENTILATOR FOR ANALYSIS. TEST VENTILATOR WAS VERIFIED BY SUCCESSFULLY RUNNING ALL TESTS AND CALIBRATION AS DETAILED IN THE 840 VENTILATOR SERVICE MANUAL. THE KEYBOARD WAS ATTACHED TO THE UNIT, POWERED UP NORMALLY, RUN SUCCESSFULLY, AND NO ERRORS WERE RECORDED IN THE DIAGNOSTIC LOGS. THE UNIT WAS SET INTO NORMAL VENTILATION MODE, AND RAN SUCCESSFULLY FOR OVER 24 HOURS. A REVIEW OF THE DIAGNOSTIC LOGS REVEALED NO ERRORS AND NO ALARMS WERE OBSERVED DURING THE RUN IN VENTILATION MODE PERIOD. PREVIOUS INVESTIGATIONS INDICATED THAT THE PROBABLE ROOT CAUSE OF THE REPORTED FAILURE COULD BE CAUSED BY CONTAMINATION ON THE PCB. THE RETURNED KEYBOARD WAS FOUND FUNCTIONING AS PER SPECIFICATIONS, AND THE REPORTED MALFUNCTION COULD NOT BE DUPLICATED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY A CUSTOMER IN THE UNITED KINGDOM THAT THE 840 VENTILATOR RESET KEY WAS INOPERATIVE. THERE WAS NO PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    511166 840 VENTILATOR CONTINUOUS VENTILATOR CBK COVIDIEN 840

    Patients

    Seq Age Sex Outcome Treatment
    1