BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    840 VENTILATOR

    MDR report key: 4060249 · Received August 4, 2014

    Report

    Report Number
    8020893-2014-01964
    Event Type
    Malfunction
    Date Received
    August 4, 2014
    Date of Event
    July 23, 2014
    Report Date
    July 23, 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 FIELD SERVICE ENGINEER (FSE) EVALUATED THE DEVICE AND VERIFIED THE REPORTED ISSUE. THE CSE REPLACED THE GRAPHIC USER INTERFACE (GUI) PRINTED CIRCUIT BOARD (PCB), WHICH RESOLVED THE REPORTED ISSUE. THE VENTILATOR PASSED CALIBRATIONS, 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 OF VENTILATOR WITH AN ERRATIC LOWER DISPLAY. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    455607 840 VENTILATOR CONTINUOUS VENTILATOR CBK COVIDIEN 840

    Patients

    Seq Age Sex Outcome Treatment
    1