BEUDAMED
    FDA Adverse Event Other Summary report: N

    SMART MONITOR 2

    MDR report key: 1943527 · Received December 3, 2010

    Report

    Report Number
    3007056120-2010-00001
    Event Type
    Other
    Date Received
    December 3, 2010
    Date of Event
    October 31, 2010
    Report Date
    November 3, 2010
    Manufacturer
    PHILIPS RESPIRONICS, INC.
    Product Code
    FLS
    PMA / PMN Number
    K011597
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO REPORT OF DEATH OR SERIOUS INJURY, AND THE MANUFACTURER WAS NOT ABLE TO CONFIRM THE ALLEGATION OF ALARM FAILURE DURING A PT EVENT. THE MONITOR PASSED ALL REQUIRED TESTING AND DETECTED AND ALARMED APPROPRIATELY FOR SIMULATED EVENTS. BASED ON ALL AVAILABLE INFO, THE MANUFACTURER CONCLUDES THAT THE DEVICE DOES FUNCTION TO SPECIFICATION AND THAT NO FURTHER ACTION IS APPROPRIATE.

    Description of Event or Problem · 1

    A USER FACILITY REPORTED, AN INFANT APNEA MONITOR DID NOT AUDIBLY ALARM DURING A CYANOTIC AND APNEIC PT EVENT ON (B)(6) 2010, AT APPROX 12:30 A.M.. THE USER FACILITY REPORTED THAT THE INFANT REQUIRED MANUAL RESUSCITATION AT THE TIME OF THE ALLEGED EVENT. THE MANUFACTURER RECEIVED THE DEVICE FOR EVALUATION AND DID NOT CONFIRM THE CUSTOMER'S COMPLAINT OF THE UNIT NOT ANNUNCIATING AN AUDIBLE ALARM. THE APNEA MONITOR WAS VISUALLY EXAMINED AND TESTED BY THE MANUFACTURER USING A SIMULATOR IN ACCORDANCE WITH THE SMARTMONITOR 2 CHECKOUT PROCEDURE MANUAL (PN 1020817). THE APNEA MONITOR DETECTED AND ALARMED APPROPRIATELY FOR SIMULATED EVENTS AND PASSED ALL REQUIRED TESTING. THE APNEA MONITOR'S MEMORY DATA WAS DOWNLOADED AND ANALYZED BY TRAINED ASSOCIATES. THE DOWNLOAD MEMORY REVEALED THE APNEA MONITOR WAS IN USE AT THE USER FACILITY FROM (B)(6) 2010 TO (B)(6) 2010 AND THERE HAD BEEN 50 PT EVENTS RECORDED DURING THAT TIME. ALL RECORDED PT EVENTS WERE ASSOCIATED WITH AUDIBLE AND VISUAL ALARMS. THE MEMORY DATA ALSO SHOWED THE APNEA MONITOR RECORDED ONE (1) EQUIPMENT EVENT AND ONE (1) PATIENT EVENT THAT WOULD HAVE PROMPTED AN AUDIBLE ALARM ON THE DAY OF THE ALLEGED EVENT. THE SMARTMONITOR 2 WAS SET UP WITH A 16 SECOND DELAY BEFORE RECORDING APNEAS AND A 20 SECOND DELAY BEFORE ANNUNCIATING AND RECORDING AN ALARM FOR AN APNEA CONDITION. THE SMARTMONITOR 2 WAS PROGRAMMED WITH PARAMETERS THAT WERE APPROPRIATE FOR RECORDING AND ALARMING FOR RESPIRATION AND HEART RATE EVENTS DURING INFANT MONITORING. THE SMARTMONITOR 2 DEVICE IS NOT INTENDED TO BE USED TO MONITOR PTS 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 PTS 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."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SMART MONITOR 2 APNEA MONITOR FLS PHILIPS RESPIRONICS, INC. 4003

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization