BEUDAMED
    FDA Adverse Event Death Summary report: N

    SMART MONITOR 2

    MDR report key: 2442422 · Received February 3, 2012

    Report

    Report Number
    3007056120-2012-00002
    Event Type
    Death
    Date Received
    February 3, 2012
    Date of Event
    January 6, 2012
    Report Date
    January 6, 2012
    Manufacturer
    PHILIPS RESPIRONICS, INC.
    Product Code
    FLS
    PMA / PMN Number
    K011597
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    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." ALTHOUGH A PT DEATH WAS REPORTED, IT HAS BEEN CONCLUDED THAT THE DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE REPORTED INCIDENT. THE MONITOR PASSED ALL REQUIRED TESTING AND DETECTED AND ALARMED APPROPRIATELY FOR SIMULATED EVENTS. BASED ON ALL AVAILABLE INFO, THE MFR 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 AN INFANT APNEA MONITOR DID NOT ALARM. THE DEVICE WAS REPORTEDLY IN PT USE AT THE TIME AND A PT DEATH HAS BEEN REPORTED. THE DME REPORTED THAT THE DOCTOR ALLEGED THAT THE HEART RATE WAS SHOWING THROUGH THE IMPEDANCE CHANNEL THEREFORE CAUSING THE MONITOR NOT TO ALARM FOR AN APNEA. THE EXACT DATE OF THE REPORTED EVENT IS NOT KNOWN. THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION AND QUALITY ASSURANCE DETERMINED THAT THE DEVICE FUNCTIONED TO SPECIFICATIONS. THE APNEA MONITOR WAS VISUALLY EXAMINED AND TESTED BY THE MFR USING A SIMULATOR IN ACCORDANCE WITH THE SMARTMONITOR 2 CHECKOUT PROCEDURE MANUAL (PN 1020817). THE APNEA MONITOR DETECTED AND ALARMED APPROPRIATE FOR SIMULATED EVENTS AND PASSED ALL REQUIRED TESTING. THE APNEA MONITOR'S MEMORY DATA WAS DOWNLOADED AND ANALYZED BY TRAINED ASSOCIATES. THE DOWNLOADED MEMORY REVEALED THAT THE SMARTMONITOR 2 WAS SET UP WITH PRESCRIBED SETTINGS OF A 16 SECOND DELAY BEFORE RECORDING APNEAS AND A 20 SECOND DELAY BEFORE ANNUNCIATING AND RECORDING AN ALARM FOR AN APNEA CONDITION. THE DOWNLOAD SHOWS THAT THE DEVICE WAS IN USE FROM (B)(6) 2011.

    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 Death