BEUDAMED
    FDA Adverse Event Death Summary report: N

    SMARTMONITOR 2

    MDR report key: 1813593 · Received August 18, 2010

    Report

    Report Number
    2518422-2010-00066
    Event Type
    Death
    Date Received
    August 18, 2010
    Date of Event
    September 1, 2009
    Report Date
    July 20, 2010
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    FLS
    PMA / PMN Number
    K011597
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A DURABLE MEDICAL EQUIPMENT (DME) SUPPLIER NOTIFIED THE MANUFACTURER OF THE DEATH OF AN INFANT WHILE A SMARTMONITOR 2, INFANT APNEA MONITOR WAS IN THE HOME. THE DATE OF DEATH WAS REPORTED AS (B)(6) 2009. THE DME INITIALLY REPORTED THAT THEY HAD DETERMINED THE APNEA MONITOR WAS NOT IN USE AT THE TIME OF DEATH BASED ON THE DATA DOWNLOADED FROM THE DEVICE MEMORY. THE PARENTS LATER ALLEGED THAT THE DEVICE WAS IN USE AND THAT THE DEVICE DID NOT AUDIBLY ALARM DURING THE ADVERSE EVENT. THE DME REPORTED THAT THE REQUIRED CHECKOUT PROCEDURE WAS PERFORMED PRIOR TO THE MONITOR BEING PLACED INTO USE ON THE INFANT AND THAT THE DEVICE PASSED ALL REQUIRED TESTING AT THAT TIME. THE MANUFACTURER RECEIVED THE APNEA MONITOR FOR EVAL. THE MONITOR WAS VISUALLY EXAMINED AND TESTED USING A SIMULATOR IN ACCORDANCE WITH THE SMART MONITOR 2 CHECKOUT PROCEDURE MANUAL (B)(4). THE APNEA MONITOR DETECTED AND ALARMED APPROPRIATELY FOR SIMULATED EVENTS AND PASSED ALL REQUIRED FUNCTIONAL TESTING. THERE WERE NO OPERATIONAL ISSUES FOUND DURING THE EVAL. THE APNEA MONITOR'S MEMORY DATA WAS DOWNLOADED AND ANALYZED BY TRAINED ASSOCIATES. THE DOWNLOADED MEMORY REVEALED THE APNEA MONITOR WAS IN USE IN THE HOME FROM (B)(6) 2009 TO (B)(6) 2009. THERE WERE FORTY ONE (41) PT EVENTS RECORDED DURING THAT TIME PERIOD, WITH THE LAST PT EVENT RECORDED ON (B)(6) 2009 AT 3:12:14 AM. THE DOWNLOAD INDICATES THAT ALL RECORDED PT EVENTS WERE ASSOCIATED WITH AUDIBLE AND VISUAL ALARMS. THE EQUIPMENT EVENTS SHOWED THE APNEA MONITOR WAS TURNED OFF ON (B)(6) 2009 AT 4:12:45 AM AND NOT TURNED ON AGAIN UNTIL (B)(6) 2009. THERE WAS NO DATA SHOWING PT USE ON THE DAY OF THE REPORTED DEATH. ALTHOUGH THERE WAS AN ALLEGATION OF DEVICE MALFUNCTION ASSOCIATED WITH THE ADVERSE EVENT, THERE IS NO EVIDENCE TO SUGGEST THE APNEA MONITOR IN ANY WAY CAUSED OR CONTRIBUTED TO THE EVENT. THE MONITOR PASSED ALL REQUIRED TESTING AND DATA SHOWS IT WAS NOT IN USE ON THE DAY OF THE EVENT. BASED ON ALL INFO AVAILABLE, THE MANUFACTURER CONCLUDES THAT NO FURTHER ACTION IS APPROPRIATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SMARTMONITOR 2 APNEA MONITOR FLS RESPIRONICS, INC. U4003

    Patients

    Seq Age Sex Outcome Treatment
    1 Death