BEUDAMED
    FDA Adverse Event Other Summary report: N

    SMART MONITOR 2

    MDR report key: 2093696 · Received April 21, 2011

    Report

    Report Number
    3007056120-2011-00009
    Event Type
    Other
    Date Received
    April 21, 2011
    Date of Event
    March 18, 2011
    Report Date
    March 25, 2011
    Manufacturer
    PHILIPS RESPIRONICS, INC.
    Product Code
    FLS
    PMA / PMN Number
    K011597
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    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 (B)(4)) 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 (B)(4)) FURTHER STATES: "THE SMART MONITOR 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 DOES FUNCTION TO SPECIFICATION AND THAT NO FURTHER ACTION IS APPROPRIATE.

    Description of Event or Problem · 1

    A DURABLE MEDICAL EQUIPMENT (DME) SUPPLIER REPORTED THAT THE MOTHER OF AN INFANT STATED THAT AN INFANT APNEA MONITOR DID NOT ALARM DURING A PATIENT EVENT. IT WAS REPORTED THAT THE INFANT HAD AN APNEIC EVENT AND CARDIOPULMONARY RESUSCITATION (CPR) HAD TO BE PERFORMED. THE ALLEGED EVENT OCCURRED ON (B)(6) 2011, DURING THE NIGHT. THE EXACT TIME OF THE EVENT IS UNKNOWN. THE DME REPORTED THAT THE INFANT WAS HOSPITALIZED THAT NIGHT AND LATER RELEASED WITHOUT PATIENT HARM. THE MANUFACTURER RECEIVED THE DEVICE FOR EVALUATION AND DID NOT CONFIRM THE CUSTOMER'S COMPLAINT OF THE UNIT NOT ALARMING. THE APNEA MONITOR WAS VISUALLY EXAMINED AND TESTED BY THE MANUFACTURER USING A SIMULATOR IN ACCORDANCE WITH THE SMARTMONITOR 2 CHECKOUT PROCEDURE MANUAL (PN (B)(4)). THE APNEA MONITOR DETECTED AND ALARMED APPROPRIATELY FOR SIMULATED EVENTS AND PASSED ALL REQUIRED TESTING. 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 APNEA MONITOR'S MEMORY DATA WAS DOWNLOADED AND ANALYZED BY TRAINED ASSOCIATES. THE DOWNLOADED MEMORY REVEALED THE APNEA MONITOR WAS IN USE FROM (B)(6) 2011. DURING THAT TIME, THERE WERE 112 RECORDED PATIENT EVENTS, OF WHICH 102 WERE RECORDED ON THE DATE OF THE ALLEGED EVENT FROM 4:03:39 AM UNTIL THE MONITOR WAS TURNED OFF AT 10:19:11AM. ALL PATIENT EVENTS THAT MET THE PARAMETERS FOR AN ALARM CONDITION WERE ASSOCIATED WITH AUDIBLE AND VISUAL ALARMS.

    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