BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    840 VENTILATOR

    MDR report key: 6081848 · Received November 7, 2016

    Report

    Report Number
    8020893-2016-02981
    Event Type
    Malfunction
    Date Received
    November 7, 2016
    Report Date
    October 11, 2016
    Manufacturer
    COVIDIEN
    Product Code
    CBK
    PMA / PMN Number
    K970460
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SERVICE ENGINEER (SE) INSPECTED THE DEVICE AND COULD NOT DUPLICATE THE ALLEGED EVENT. THE UNIT PASSED ALL TESTING AND OPERATES WITHIN THE MANUFACTURING SPECIFICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN 840 VENTILATOR GENERATED AN ERROR WHICH RENDERED THE VENTILATOR INOPERABLE. THE VENTILATOR WAS NOT IN USE ON A PATIENT AT THE TIME THE EVENT OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    735221 840 VENTILATOR CONTINUOUS VENTILATOR CBK COVIDIEN 840

    Patients

    Seq Age Sex Outcome Treatment
    1