BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    840 VENTILATOR

    MDR report key: 3851813 · Received April 11, 2014

    Report

    Report Number
    8020893-2014-00874
    Event Type
    Malfunction
    Date Received
    April 11, 2014
    Report Date
    March 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
    AL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT MADE AVAILABLE TO THE MANUFACTURER FOR INVESTIGATION. COVIDIEN REFERENCE: (B)(4).

    Description of Event or Problem · 1

    A REPORT WAS REC'D FROM THE USA INDICATING THAT THE DEVICE HAD AN ERRATIC DISPLAY. THERE WAS NO INFO RELATED TO PATIENT INVOLVEMENT OR A DATE OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    221260 840 VENTILATOR CBK COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT IRELAND 840

    Patients

    Seq Age Sex Outcome Treatment
    1