BEUDAMED
    FDA Adverse Event Death Summary report: N

    HUMID VENT FILTER LIGHT

    MDR report key: 181036 · Received August 4, 1998

    Report

    Report Number
    1824054-1998-00001
    Event Type
    Death
    Date Received
    August 4, 1998
    Date of Event
    January 1, 1998
    Report Date
    April 8, 1998
    Manufacturer
    LOUIS GIBECK AB
    Product Code
    BYD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE VERY BRIEF INFO ABOUT EVENT IS DUE TO THE DIFFICULTIES TO ESTABLISH CONTACT WITH THE RESPONSIBLE PERSON AT THE HOSP. BY E-MAIL, CO'S DIST GIBECK INC, REPORTED THAT AN INCIDENT HAD HAPPENED AT HOSP. SOURCE HAD REPORTED BY A PHONE CALL THAT A PT HAD EXPIRED WHILE ATTACHED TO A PLV VENTILATOR. THE BREATHING CIRCUIT USED INCLUDED A LOUIS GIBECK AB 19932 HUMID VENT FILTER LIGHT. THE CIRCUIT DISCONNECT OCCURRED WITHOUT ACTIVATING THE ALARM FUNCTION OF THE PLV VENTILATOR, WHICH WAS REPORTED TO BE THE REASON FOR THE INCIDENT. THE RESPONSIBLE QA PERSONS AT LOUIS GIBECK AND GIBECK INC HAVE CALLED SEVERAL TIMES, SENT SEVERAL E-MAILS AND FAXED TO SOURCE IN ORDER TO GET MORE CLARIFYING INFO ABOUT THE CIRCUMSTANCES FOR THE INCIDENT AND THE EXACT CIRCUIT CONNECTION AND ASK FOR THE HUMID VENT FILTER LIGHT TO BE RETURNED TO CO FOR INSPECTION AND TESTING. CO HAS, SO FAR, NOT BEEN ABLE TO ESTABLISH CONTACT TO SOURCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUMID VENT FILTER LIGHT FILTER HME BYD LOUIS GIBECK AB 19932 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO 1. PLV VENTILATOR NI.| 2. CIRCUIT NI.