BEUDAMED
    FDA Adverse Event Death Summary report: N

    SMARTMONITOR 2

    MDR report key: 2042967 · Received March 31, 2011

    Report

    Report Number
    3007056120-2011-00007
    Event Type
    Death
    Date Received
    March 31, 2011
    Date of Event
    February 5, 2011
    Report Date
    March 1, 2011
    Manufacturer
    PHILIPS RESPIRONICS, INC.
    Product Code
    FLS
    PMA / PMN Number
    K011597
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH THERE WAS A DEATH REPORTED, THE MANUFACTURER CONCLUDED THAT THE DEVICE DID NOT CAUSE NOR CONTRIBUTE TO THE INFANT DEATH. THE MANUFACTURER WAS NOT ABLE TO CONFIRM THE ALLEGATION OF ALARM FAILURE DURING A PATIENT EVENT AND DETERMINED THAT THE DEVICE WAS NOT IN USE DURING THE 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 AN INFANT APNEA MONITOR DID NOT ALARM DURING AN APNEIC EVENT AND THE PATIENT EXPIRED AS A RESULT. THE DME STATED THAT THE MOTHER OF THE INFANT ADMINISTERED CARDIOPULMONARY RESUSCITATION (CPR) AND THE EQUIPMENT DID NOT ALARM. THE REPORTED EVENT OCCURRED ON (B)(6), 2011 AT 10:15 AM. THE MANUFACTURER RECEIVED THE DEVICE FOR EVALUATION AND DID NOT CONFIRM THE CUSTOMER'S COMPLAINT OF THE UNIT NOT ALARMING. THE INFANT 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 INFANT APNEA MONITOR DETECTED AND ALARMED APPROPRIATELY FOR SIMULATED EVENTS AND PASSED ALL REQUIRED TESTING. THE SMARTMONITOR 2 WAS SET UP WITH 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. FURTHERMORE, THE INFANT APNEA MONITOR'S MEMORY DATA WAS DOWNLOADED AND ANALYZED BY TRAINED ASSOCIATES. THE DOWNLOADED MEMORY REVEALED THE APNEA MONITOR WAS NOT IN USE DURING THE TIME OF THE REPORTED EVENT. THE DEVICE WAS TURNED OFF ON (B)(6), 2011 AT 3:59:05 AM AND NOT TURNED BACK ON UNTIL (B)(6), 2011 AT 1:30:52 PM. 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 THE PROPER WAY TO RESTORE BREATHING AND HEART ACTIVITY."

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Death