BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    840 VENTILATOR

    MDR report key: 1082707 · Received July 23, 2008

    Report

    Report Number
    8020893-2008-00359
    Event Type
    Malfunction
    Date Received
    July 23, 2008
    Date of Event
    July 9, 2008
    Report Date
    July 14, 2008
    Manufacturer
    PURITAN-BENNET CORP
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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 BENNET CUSTOMER SUPPORT ENGINEER (CSE) CONDUCTED FINAL TESTING.

    Description of Event or Problem · 1

    THE SVC 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 840 VENTILATOR VENTILATOR CBK PURITAN-BENNET CORP 840

    Patients

    Seq Age Sex Outcome Treatment
    1