BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    840 VENTILATOR

    MDR report key: 4140780 · Received October 3, 2014

    Report

    Report Number
    8020893-2014-02296
    Event Type
    Malfunction
    Date Received
    October 3, 2014
    Report Date
    September 4, 2014
    Manufacturer
    COVIDIEN
    Product Code
    CBK
    PMA / PMN Number
    K970460
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COVIDIEN CUSTOMER SUPPORT ENGINEER (CSE) EVALUATED THE DEVICE AND VERIFIED THE REPORTED ISSUE. THE CSE FOUND THE DISPLAY TO BE MISSING SEGMENTS. THE CSE REPLACED THE GRAPHIC USER INTERFACE (GUI) PRINTED CIRCUIT BOARD (PCB), WHICH RESOLVED THE REPORTED ISSUE. THE VENTILATOR PASSED EXTENDED SELF-TESTING (EST), SHORT SELF-TESTS (SST), PERFORMANCE VERIFICATION TESTING (PVT), AND ELECTRICAL SAFETY TESTS. (B)(4).

    Description of Event or Problem · 1

    COVIDIEN RECEIVED INFORMATION STATING AN 840 VENTILATOR EXPERIENCED A FLICKERING SCREEN. THE MALFUNCTION DID NOT OCCUR DURING PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    620119 840 VENTILATOR CONTINUOUS VENTILATOR CBK COVIDIEN 840

    Patients

    Seq Age Sex Outcome Treatment
    1