BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMART MONITOR 2

    MDR report key: 1954632 · Received October 14, 2010

    Report

    Report Number
    2518422-2010-00100
    Event Type
    Malfunction
    Date Received
    October 14, 2010
    Date of Event
    August 23, 2010
    Report Date
    September 14, 2010
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    FLS
    PMA / PMN Number
    K011597
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    IN ADDITION, THE USER FACILITY PERFORMED THE CHECKOUT PROCEDURE (PN 1020818) DURING THE EVALUATION AND CONFIRMED THAT ALL AUDIBLE AND VISUAL ALARMS FUNCTIONED TO THE MANUFACTURER'S SPECIFICATIONS. THE USER FACILITY STATED THE DEVICE WOULD NOT BE RETURNING TO THE MANUFACTURER. THE USER FACILITY PERFORMED A DOWNLOAD OF THE MONITOR'S MEMORY DATA AND SENT THE RESULTS TO THE MANUFACTURER FOR REVIEW. THE MONITOR'S MEMORY DATA WERE ANALYZED BY TRAINED ASSOCIATES. THE DOWNLOADED MEMORY REVEALED THE APNEA MONITOR WAS IN USE IN THE HOME FROM (B)(6) 2010. THERE WERE FIVE (5) PATIENT EVENTS RECORDED DURING THAT TIME. THE MANUFACTURER CONFIRMED THE RESULTS OF THE USER FACILITY AND ALL VISUAL AND AUDIBLE ALARMS FUNCTIONED TO SPECIFICATIONS. THERE WERE NO PATIENT EVENTS RECORDED ON THE DATE OF THE ALLEGED EVENT. THE SMARTMONITOR 2 WAS PROGRAMMED WITH PARAMETERS THAT WERE APPROPRIATE FOR RECORDING AND ALARMING FOR RESPIRATION AND HEART RATE EVENTS DURING INFANT MONITORING. FURTHERMORE, THE RISK MANAGER FROM THE USER FACILITY STATED THAT THE INFANT WAS BEING FED DURING THE TIME OF THE ALLEGED EVENT AND MAY HAVE HAD A "CHOKING SPELL" CAUSING A COLOR CHANGE IN THE INFANT. THE RISK MANAGER ALSO STATED AT NO TIME DID THE INFANT EXPERIENCE AN APNEIC EVENT. THE SMARTMONITOR 2 DEVICE IS NOT INTENDED TO BE USED TO MONITOR PATIENTS FOR CYANOSIS AND HAS NO CAPABILITY TO DO SO. THE SMARTMONITOR 2 PARENTS' GUIDE (PN 572-4000-00) STATES IN THE INDICATIONS FOR USE: "THE SMARTMONITOR 2 IS INTENDED FOR USE IN CONTINUOUS MONITORING OF HEART RATE AND RESPIRATION OF INFANT PATIENTS IN A HOME, HOSPITAL OR PORTABLE ENVIRONMENT. ITS PRIMARY FUNCTION IS DETECTION OF CENTRAL APNEA. ITS SECONDARY FUNCTION IS MEASUREMENT OF HEART RATE. THE SMARTMONITOR 2 DEVICE IS NOT INTENDED TO PREVENT LOSS OF BREATHING OR HEART ACTIVITY. THE SMARTMONITOR 2 PARENTS' GUIDE (PN 572-4000-00) FURTHER STATES: THE SMARTMONITOR 2 IS A MONITORING DEVICE ONLY. IT DOES NOT PREVENT THE LOSS OF BREATHING OR HEART ACTIVITY, NOR WILL IT RESTORE BREATHING OR HEART ACTIVITY. IT WILL NOT PREVENT DEATH. ANYONE USING THE SMARTMONITOR 2 TO MONITOR AN INFANT SHOULD BE TRAINED IN CURRENT INFANT CARDIOPULMONARY RESUSCITATION (CPR), WHICH IS A PROPER WAY TO RESTORE BREATHING AND HEART ACTIVITY." THERE WAS NO REPORT OF DEATH OR SERIOUS INJURY AND THE MANUFACTURER WAS NOT ABLE TO CONFIRM THE ALLEGATION OF ALARM FAILURE DURING A PATIENT EVENT. THE MONITOR PASSED ALL REQUIRED TESTING AND DETECTED AND ALARMED APPROPRIATELY FOR SIMULATED EVENTS. BASED ON ALL AVAILABLE INFORMATION, THE MANUFACTURER CONCLUDES THAT THE DEVICE FUNCTIONED TO SPECIFICATION AND THAT NO FURTHER ACTION IS APPROPRIATE.

    Description of Event or Problem · 1

    THE MANUFACTURER RECEIVED A VOLUNTARY MEDWATCH REPORT (B)(4) FROM A USER FACILITY REPORTING AN ALLEGED EVENT IN WHICH A PARENT REPORTED THAT AN INFANT PATIENT EXPERIENCED A CYANOTIC EVENT WITH NO AUDIBLE APNEA ALARM FROM THE APNEA MONITOR (SMARTMONITOR 2) DURING USE. THE DATE OF THE ALLEGED EVENT IS (B)(6) 2010. THE USER FACILITY PERFORMED AN EVALUATION OF THE DEVICE AFTER THE ALLEGED EVENT. THE ALLEGATION THAT THE MONITOR DID NOT ALARM COULD NOT BE CONFIRMED BY THE USER FACILITY. THE SMARTMONITOR 2 DEVICE IS DESIGNED TO ALARM FOR APNEA ONLY AFTER THE DEVICE DOES NOT DETECT PATIENT RESPIRATION FOR A PRESCRIBED DELAY. THE SMARTMONITOR 2 DEVICE WAS SET UP WITH A PRESCRIBED DELAY OF 20 SECONDS. THE USER FACILITY ANALYZED THE DEVICE'S MEMORY DATA AND REPORTED A 16 SECOND APNEA EVENT HAD OCCURRED ON (B)(6) 2010 WHICH WAS WITHIN THE PRESCRIBED 20 SECOND DELAY. THERE WAS NO ALARM ASSOCIATED WITH THIS APNEA. THE USER FACILITY ALSO REPORTED A 22 SECOND APNEA EVENT ALARM HAD OCCURRED AND CONFIRMED THE EVENT WAS ACCOMPANIED WITH AN AUDIBLE AND VISUAL ALARM. THE REFERENCED APNEA OCCURRENCES WERE WITHIN THE PARAMETERS OF THE DEFAULT ALARMS AND THE DELAY SET IN THE MONITOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SMART MONITOR 2 APNEA MONITOR FLS RESPIRONICS, INC. 4002

    Patients

    Seq Age Sex Outcome Treatment
    1