BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    840 VENTILATOR

    MDR report key: 2801245 · Received October 17, 2012

    Report

    Report Number
    8020893-2012-00971
    Event Type
    Malfunction
    Date Received
    October 17, 2012
    Manufacturer
    COVIDIEN, FORMERLY NELLCOR
    Product Code
    CBK
    PMA / PMN Number
    K970460
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT AN 840 VENTILATOR STOPPED CYCLING. NO PT INVOLVEMENT. COVIDIEN WAS NOT AUTHORIZED TO REPAIR THE UNIT. THE CUSTOMER INSPECTED THE DEVICE AND COULD NOT DUPLICATE THE REPORTED FAILURE. NO PARTS WERE REPLACED. THE UNIT PASSED EXTENDED SELF TESTING. IT IS NOT VERIFIED THAT THE VENT WAS INOPERABLE, AND THAT A MALFUNCTION OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 840 VENTILATOR VENTILATOR CBK COVIDIEN, FORMERLY NELLCOR 840

    Patients

    Seq Age Sex Outcome Treatment
    1