BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    840 VENT USA

    MDR report key: 3853590 · Received April 3, 2014

    Report

    Report Number
    8020893-2014-00791
    Event Type
    Malfunction
    Date Received
    April 3, 2014
    Report Date
    March 6, 2014
    Manufacturer
    COVIDIEN, FORMERLY NELLCOR PURITAN
    Product Code
    CBK
    PMA / PMN Number
    K970460
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS TESTED AND PASSED EXTENDED SELF TESTING (EST) AND THE DEVICE WAS RUN ON A TEST LUNG FOR SEVERAL DAYS. THE EVENT COULD NOT BE DUPLICATED. COVIDIEN REF: (B)(4).

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED FROM THE USA INDICATING THAT THE DEVICE EXPERIENCED A LOSS OF VENTILATION ERROR. THERE WAS NO REPORTED PT INVOLVEMENT. THE DATE OF THE EVENT WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202594 840 VENT USA CBK COVIDIEN, FORMERLY NELLCOR PURITAN 840

    Patients

    Seq Age Sex Outcome Treatment
    1