BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    840 VENTILLATOR

    MDR report key: 1000744 · Received February 21, 2008

    Report

    Report Number
    8020893-2008-00071
    Event Type
    Malfunction
    Date Received
    February 21, 2008
    Date of Event
    January 27, 2008
    Report Date
    January 29, 2008
    Manufacturer
    PURITAN-BENNETT CORP
    Product Code
    CBK
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE SVC REPORT SHOWS THE CUSTOMER REPORTED THAT THE 840 VENTILATOR STOPPED CYCLING WHILE IN USE ON THE PT. THE PT WAS NOT HARMED OR INJURED AS A RESULT OF THE EVENT. THE PURITAN BENNETT CUSTOMER SUPPORT ENGINEER (CSE) VERIFIED THE MALFUNCTION. THE CSE INSPECTED THE DEVICE AND REPLACED THE MOTHERBOARD AND AI BOARD. THE UNIT PASSED EXTENDED SELF TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 840 VENTILLATOR VENTILLATOR CBK PURITAN-BENNETT CORP 840 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK