BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    840 VENTILATOR

    MDR report key: 3905673 · Received May 28, 2014

    Report

    Report Number
    8020893-2014-01283
    Event Type
    Malfunction
    Date Received
    May 28, 2014
    Date of Event
    January 1, 2014
    Report Date
    April 29, 2014
    Manufacturer
    COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT IRELAND
    Product Code
    CBK
    PMA / PMN Number
    K970460
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COVIDIEN CUSTOMER SUPPORT ENGINEER (CSE) INSPECTED THE DEVICE AND VERIFIED THE REPORTED ISSUE. THE CSE REPLACED THE MOTHER BOARD AND INSPIRATORY BLIND MATE CABLE TO RESOLVE THE ISSUE. THE DEVICE PASSED ALL CALIBRATIONS, SHORT SELF-TEST (SST), EXTENDED SELF-TEST (EST) AND PERFORMANCE VERIFICATION TESTING ACCORDING TO MFR SPECIFICATIONS. (B)(4).

    Description of Event or Problem · 1

    A REPORT RECEIVED FROM THE USA STATED AN 840 VENTILATOR EXPERIENCED A DEVICE ALERT WHICH RENDERED THE VENTILATOR INOPERABLE. THERE WAS NO PT INVOLVEMENT AT THE TIME OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    315107 840 VENTILATOR CBK COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT IRELAND 840

    Patients

    Seq Age Sex Outcome Treatment
    1