BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    840 VENTILAOR

    MDR report key: 2943100 · Received January 21, 2013

    Report

    Report Number
    8020893-2013-00174
    Event Type
    Malfunction
    Date Received
    January 21, 2013
    Date of Event
    December 22, 2012
    Report Date
    December 25, 2012
    Manufacturer
    COVIDIEN, FORMERLY NELLCOR
    Product Code
    CBK
    PMA / PMN Number
    K970460
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE 840 VENTILATOR STOPPED CYCLING. THERE IS NO PATIENT INVOLVEMENT. THE EVALUATION OF THE DEVICE HAS NOT BEEN COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28876 840 VENTILAOR VENTILATOR CBK COVIDIEN, FORMERLY NELLCOR 840

    Patients

    Seq Age Sex Outcome Treatment
    1