BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    840 VENTILATOR

    MDR report key: 1082618 · Received July 23, 2008

    Report

    Report Number
    8020893-2008-00364
    Event Type
    Malfunction
    Date Received
    July 23, 2008
    Date of Event
    July 13, 2008
    Report Date
    July 15, 2008
    Manufacturer
    PURITAN-BENNETT CORP.
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PURITAN BENNETT WAS NOT AUTHORIZED TO REPAIR THE UNIT. THE CUSTOMER REPORTED TO HAVE REPLACED THE BDU CPU. THE PURITAN BENNETT CUSTOMER SUPPORT ENGINEER (CSE) CONDUCTED FINAL TESTING. SEE SCANNED PAGE.

    Description of Event or Problem · 1

    THE SERVICE REPORT SHOWS THE CUSTOMER REPORTED THAT THE 840 VENTILATOR STOPPED CYCLING WHILE IN USE ON A PATIENT. THE PATIENT 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