BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    840 VENTILATOR

    MDR report key: 2090192 · Received April 11, 2011

    Report

    Report Number
    8020893-2011-00165
    Event Type
    Malfunction
    Date Received
    April 11, 2011
    Date of Event
    April 4, 2011
    Report Date
    April 4, 2011
    Manufacturer
    PURITAN BENNETT CORP.
    Product Code
    CBK
    PMA / PMN Number
    K970460
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER CONTACTED COVIDIEN TECHNICAL SUPPORT AND HE MENTIONED THAT THE UNIT PASSED ALL TESTS AND CALIBRATIONS AND RAN OVER THE WEEKEND ON A TEST LUNG WITH NO PROBLEMS. CUSTOMER WAS NOT ABLE TO DUPLICATE THE ALLEGED MALFUNCTION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED 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 PURITAN BENNETT CORP. 840

    Patients

    Seq Age Sex Outcome Treatment
    1