BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTILATOR, CONTINUOUS, FACILITY USE

    MDR report key: 2243993 · Received August 24, 2011

    Report

    Report Number
    2518422-2011-00101
    Event Type
    Malfunction
    Date Received
    August 24, 2011
    Date of Event
    August 15, 2011
    Report Date
    August 15, 2011
    Manufacturer
    RESPIRONICS INC
    Product Code
    CBK
    PMA / PMN Number
    K083526
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE LABELING (TRILOGY CLINICAL MANUAL, PN (B)(4)) CONTAINS WARNING TO INDICATE DILIGENT TESTING OF A REMOTE ALARM OR NURSE CALL SYSTEM IS REQUIRED PRIOR TO PT USE: WHEN USING A REMOTE ALARM, MAKE SURGE YOU FULLY TEST THE REMOTE ALARM CONNECTOR AND CABLE BY VERIFYING THAT: ANNUNCIATED ALARMS ON THE VENTILATOR ARE ALSO ANNUNCIATED ON THE REMOTE ALARM. DISCONNECTING THE REMOTE ALARM CABLE FROM THE VENTILATOR OR FROM THE REMOTE ALARM RESULTS IN AN ALARM NOTIFICATION AT THE REMOTE ALARM . THE REMOTE ALARM SHOULD BE TESTED DAILY. THE USE OF THE VENTILATOR'S REMOTE ALARM OR NURSE CALL SYSTEM OPTIONS ARE TO BE CONSIDERED AS A BACK-UP TO THE DEVICE'S PRIMARY AUDIBLE ALARMS. DEVICE LABELING (TRILOGY CLINICAL MANUAL, PN (B)(4)) STATES: THE NURSE CALL FEATURE SHOULD BE CONSIDERED A BACK UP TO THE TRILOGY DEVICE'S PRIMARY ALARM SYSTEM. DO NOT RELY SOLELY ON THE NURSE CALL FEATURE. DO NOT RELY ON THE AUDIBLE INDICATOR PROVIDED BY THE NURSE CALL SYSTEM AS THE PRIMARY INDICATOR OF THE OPERATING STATE OF THE DEVICE OR OF PT EVENTS. THE TRILOGY'S NURSE CALL FEATURE IS FOR USE ONLY IN A MEDICALLY SUPERVISED ENVIRONMENT. DEVICE LABELING IS ADEQUATE TO INFORM THE USER OR CAREGIVER OF THE DEVICE THAT REMOTE ALARM OR NURSE CALL OPTIONS ARE TO BE CONSIDERED A BACK-UP TO THE DEVICE'S PRIMARY AUDIBLE ALARMS IN A MEDICALLY SUPERVISED ENVIRONMENT, AND THAT CONFIRMATION OF THE REMOTE ALARM OR NURSE CALL CONNECTOR IS REQUIRED PRIOR TO PLACING THE DEVICE INTO PT USE. ALTHOUGH THE MALFUNCTION OF THE VENTILATOR'S REMOTE ALARM CONNECTOR COULD CAUSE A FAILURE OF A REMOTE ALARM OR NURSE CALL SYSTEM TO ANNUNCIATE IF CONFIGURED TO NORMALLY OPEN, DEVICE LABELING WARNS USERS OF THIS POSSIBILITY. A FAILURE OF THE VENTILATOR'S REMOTE ALARM CONNECTOR WOULD NOT AFFECT THE DEVICE'S PRIMARY ALARMS OR FUNCTION. THE VENTILATOR WOULD CONTINUE TO PROVIDE THERAPY AND AUDIBLY ALARM FOR PT EVENTS. TO DATE THERE HAVE BEEN NO REPORTS OF PT HARM OR INJURY RELATED TO REMOTE ALARM/NURSE CALL CONNECTOR FAILURES.

    Description of Event or Problem · 1

    A MALFUNCTION OF A VENTILATOR'S REMOTE ALARM/NURSE CALL CONNECTOR WAS IDENTIFIED AT THE MFR'S SERVICE CENTER DURING EVAL FOR AN UNRELATED ISSUE. THERE WAS NO ALLEGATION OF PT HARM. 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. 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 MFR'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 CONFIGURATION. A MALFUNCTION OF THE VENTILATOR'S REMOTE ALARM CONNECTOR, CABLE, OR OTHER RELATED COMPONENT COULD CAUSE A FAILURE TO INITIATE A REMOTE OPEN CONFIGURATION. THIS TYPE OF CONFIGURATION IS NOT RECOMMENDED BY THE MFR. THE VENTILATOR WOULD NOT WARN OR ALERT THE USER OF A REMOTE ALARM OR NURSE LABELING FOR THE DEVICE (NURSE CALL ADAPTOR CABLE, PN (B)(4)) LISTS THE FOLLOWING WARNING FOR USE IN A "NORMALLY OPEN' REMOTE ALARM OR NURSE CAL 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."

    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