BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTILATOR, CONTINUOUS, FACILITY USE

    MDR report key: 1935398 · Received November 17, 2010

    Report

    Report Number
    2518422-2010-00130
    Event Type
    Malfunction
    Date Received
    November 17, 2010
    Date of Event
    November 12, 2010
    Report Date
    November 12, 2010
    Manufacturer
    RESPIRONICS INC.
    Product Code
    CBK
    PMA / PMN Number
    K083467
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS TYPE OF MALFUNCTION WOULD CAUSE CONTINUOUS ACTIVATION (CONTINUOUS ALARM STATE) OF A REMOTE ALARM OR NURSE CALL SYSTEM IF THE VENTILATOR WAS BEING USED WITH A "NORMALLY CLOSED" OR "LIFECARE" CONFIGURATION. THESE ARE THE MANUFACTURER'S RECOMMENDED REMOTE ALARM CONNECTOR SETTINGS AND WOULD ALERT THE USER OR CAREGIVER OF AN EVENT IF THE REMOTE ALARM CONNECTOR, CABLE, OR OTHER RELATED COMPONENT FAILED TO OPERATE AS DESIGNED. THE VENTILATOR'S REMOTE ALARM CONNECTOR CAN ALSO INTERFACE WITH A "NORMALLY OPEN" REMOTE ALARM OR NURSE CALL SYSTEM. A MALFUNCTION OF THE VENTILATOR'S REMOTE ALARM CONNECTOR, CABLE, OR OTHER RELATED COMPONENT COULD CAUSE A FAILURE TO INITIATE A REMOTE ALARM OR NURSE CALL SYSTEM WHEN USED WITH A NORMALLY OPEN CONFIGURATION. THIS TYPE OF CONFIGURATION IS NOT RECOMMENDED BY THE MANUFACTURER. THE VENTILATOR WOULD NOT WARN OR ALERT THE USER OF THE REMOTE ALARM OR NURSE CALL SYSTEM FAILURE IF A FAILURE WERE TO OCCUR. LABELING FOR THE DEVICE (NURSE CALL ADAPTOR CABLE, PN 1055061) LISTS THE FOLLOWING WARNING FOR USE IN A "NORMALLY OPEN" REMOTE ALARM OR NURSE CALL CONFIGURATION: "RESPIRONICS STRONGLY RECOMMENDS USING A NORMALLY CLOSED NURSE CALL SYSTEM. IF A SYSTEM WITH NORMALLY OPEN LOGIC IS USED THERE ARE CERTAIN SITUATIONS WHERE THE NURSE CALL SYSTEM CANNOT INDICATE AN ALARM CONDITION."

    Description of Event or Problem · 1

    A MALFUNCTION OF A VENTILATOR'S REMOTE ALARM/NURSE CALL CONNECTOR WAS IDENTIFIED AT THE MANUFACTURER'S SERVICE CENTER DURING EVALUATION FOR AN UNRELATED ISSUE. THE DEVICE'S REMOTE ALARM CONNECTOR APPEARED TO HAVE BEEN STRESSED BEYOND ITS INTENDED DESIGN. THE SOLDER JOINTS THAT ATTACH THE REMOTE ALARM CONNECTOR TO THE INTERFACE BOARD WERE FRACTURED, CAUSING AN "OPEN" CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VENTILATOR, CONTINUOUS, FACILITY USE TRILOGY 100 CBK RESPIRONICS INC. 1054260

    Patients

    Seq Age Sex Outcome Treatment
    1