BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    840 VENTILATOR

    MDR report key: 1002143 · Received February 25, 2008

    Report

    Report Number
    8020893-2008-00080
    Event Type
    Malfunction
    Date Received
    February 25, 2008
    Date of Event
    February 14, 2008
    Report Date
    February 15, 2008
    Manufacturer
    PURITAN-BENNETT CORP.
    Product Code
    CBK
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    OTHER

    Narratives

    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 INJURIES AS A RESULT OF THE EVENT. THE PURITAN BENNETT CUSTOMER SUPPORT ENGINEER (CSE) VERIFIED, BUT COULD NOT DUPLICATE THE MALFUNCTION. THE UNIT PASSED EXTENDED SELF TESTING.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK