BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    840 VENTILATOR

    MDR report key: 2093117 · Received April 15, 2011

    Report

    Report Number
    8020893-2011-00180
    Event Type
    Malfunction
    Date Received
    April 15, 2011
    Date of Event
    March 30, 2011
    Report Date
    March 30, 2011
    Manufacturer
    PURITAN BENNETT CORP.
    Product Code
    CBK
    PMA / PMN Number
    K970460
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PURITAN BENNETT CUSTOMER SUPPORT ENGINEER (CSE) INSPECTED THE DEVICE AND ADJUSTED THE EXHALATION FILTER SEAL AND LATCH. NO PARTS WERE REPLACED. THE UNIT PASSED EXTENDED SELF TESTING.

    Description of Event or Problem · 1

    THE SERVICE REPORT SHOWS 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. 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 PURITAN BENNETT CORP. 840

    Patients

    Seq Age Sex Outcome Treatment
    1