BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    840 VENTILATOR

    MDR report key: 4092669 · Received August 19, 2014

    Report

    Report Number
    8020893-2014-02071
    Event Type
    Malfunction
    Date Received
    August 19, 2014
    Date of Event
    August 8, 2014
    Report Date
    August 8, 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

    ADDITIONAL AND CLARIFYING INFORMATION WAS RECEIVED, WHERE THE AFFILIATE CONFIRMED THAT THE REPORTED EVENT OCCURRED DURING POWER ON SELF-TEST (POST), AND WHILE TESTING THE VENTILATOR PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. BECAUSE THIS INCIDENT OCCURRED DURING THE SYSTEM SELF-TEST PROCESS AND BEFORE PATIENT USE, THIS IS NO LONGER CONSIDERED AS AN MDR REPORTABLE EVENT.

    Additional Manufacturer Narrative · 1

    THE COVIDIEN CUSTOMER SUPPORT ENGINEER (CSE) VERIFIED THE MALFUNCTION. THE CSE INSPECTED THE DEVICE AND REPLACED THE BREATH DELIVERY UNIT (BDU) PRINTED CIRCUIT BOARD (PCB). THE CSE PERFORMED EXTENDED SELF-TESTING ON THE DEVICE AND ALL TESTS PASSED. (B)(4).

    Additional Manufacturer Narrative · 1

    THE BREATH DELIVERY PRINTED CIRCUIT BOARD WAS RETURNED FOR INVESTIGATION AND PLACED IN A TEST VENTILATOR. THE RETURNED COMPONENT PASSED POST (POWER ON SELF-TEST), CALIBRATIONS, EST (EXTENDED SELF-TEST) AND SST (SHORT SELF-TEST), AND PERFORMANCE VERIFICATION AS DETAILED IN THE 840 VENTILATOR SERVICE MANUAL. THE COVIDIEN INVESTIGATOR CONFIRMED THE COMPONENT IS IN OPERATING CONDITIONS AND PER THE MANUFACTURER¿S SPECIFICATIONS. THE REPORTED MALFUNCTION WAS NOT VERIFIED. THEREFORE, NO ROOT CAUSE CAN BE ATTRIBUTED TO THE REPORTED MALFUNCTION. WE WILL CONTINUE TO MONITOR THIS ISSUE FOR TRENDS.

    Description of Event or Problem · 1

    COVIDIEN REC'D INFO STATING THAT AN 840 VENTILATOR WAS INOPERABLE. THE VENTILATOR WAS NOT IN USE ON A PATIENT AT THE TIME THE MALFUNCTION OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    496843 840 VENTILATOR CONTINUOUS VENTILATOR CBK COVIDIEN 840

    Patients

    Seq Age Sex Outcome Treatment
    1