Description of Event or Problem · 1
A VENTILATOR WAS RETURNED TO THE MFR¿S SERVICE CENTER WITH A COMPLAINT THE REMOTE ALARM/NURSE CALL CONNECTOR WAS BROKEN. THE VENTILATOR WAS EVALUATED AND THE CUSTOMER¿S COMPLAINT WAS CONFIRMED. 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 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 MFR. THE VENTILATOR WOULD NOT WARN OR ALERT THE USER OF A REMOTE ALARM OR NURSE CALL SYSTEM FAILURE IF A FAILURE WERE TO OCCUR. 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 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.¿ DEVICE LABELING (B)(4) CONTAINS WARNINGS TO INDICATE DILIGENT TESTING OF A REMOTE ALARM OR NURSE CALL SYSTEM IS REQUIRED PRIOR TO PT USE: WHEN USING A REMOTE ALARM, MAKE SURE 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 TO 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 (B)(4) STATES: THE NURSE CALL FEATURE SHOULD BE CONSIDERED A BACK-UP TO THE (B)(6) 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 (B)(6) 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. BASED ON DEVICE LABELING AND NO REPORTED PT ADVERSE EVENT, THE MFR CONCLUDES NO FURTHER ACTION IS REQUIRED.