BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    840 VENTILATOR

    MDR report key: 2160439 · Received June 20, 2011

    Report

    Report Number
    8020893-2011-00268
    Event Type
    Malfunction
    Date Received
    June 20, 2011
    Date of Event
    May 25, 2011
    Report Date
    June 3, 2011
    Manufacturer
    COVIDIEN, FORMERLY NELLCOR PURITAN
    Product Code
    CBK
    PMA / PMN Number
    K970460
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    COVIDIEN CSE PERFORMED SOFTWARE UPGRADE ONLY. CUSTOMER REPLACED THE BDU CPU PCB. THE INVESTIGATION AND SERVICE WERE REPORTED TO BE COMPLETED BY THE CUSTOMER. THE DEVICE PASSED ALL FUNCTIONAL TESTS REQUIRED FOR THIS PRODUCT.

    Description of Event or Problem · 1

    THE SERVICE REPORT SHOWS THAT THE 840 VENTILATOR STOPPED CYCLING WHILE IN USE ON A PT. THE PT WAS NOT HARMED OR INJURED AS A RESULT OF THE EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1