BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    840 VENTILATOR

    MDR report key: 3955677 · Received June 11, 2014

    Report

    Report Number
    8020893-2014-01409
    Event Type
    Malfunction
    Date Received
    June 11, 2014
    Date of Event
    May 14, 2014
    Report Date
    May 14, 2014
    Manufacturer
    COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT IRELAND
    Product Code
    CBK
    PMA / PMN Number
    K970460
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COVIDIEN CUSTOMER SUPPORT ENGINEER (CSE) EVALUATED THE DEVICE AND FOUND A DAMAGED OXYGEN SENSOR. THE CSE REPLACED THE OXYGEN SENSOR, WHICH RESOLVED THE CUSTOMER REPORTED ISSUE. THE VENTILATOR PASSED CALIBRATIONS, SHORT SELF TESTS (SST), EXTENDED SELF-TESTING (EST), AND SAFETY AND FUNCTIONALITY TESTING. (B)(4).

    Description of Event or Problem · 1

    A REPORTED RECEIVED FROM THE USA STATED AN 840 VENTILATOR EXPERIENCED AN OXYGEN SENSOR ERROR. THERE WAS NO PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    345082 840 VENTILATOR CBK COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT IRELAND 840

    Patients

    Seq Age Sex Outcome Treatment
    1