BEUDAMED
    FDA Adverse Event Death Summary report: N

    SMART MONITOR 2

    MDR report key: 2632320 · Received June 21, 2012

    Report

    Report Number
    3007056120-2012-00013
    Event Type
    Death
    Date Received
    June 21, 2012
    Date of Event
    May 14, 2012
    Report Date
    May 29, 2012
    Manufacturer
    PHILIPS RESPIRONICS, INC
    Product Code
    FLS
    PMA / PMN Number
    K011597
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE SMART MONITOR WAS PROGRAMMED WITH PARAMETERS THAT WERE APPROPRIATE FOR RECORDING AND ALARMING FOR RESPIRATION AND HEART RATE EVENTS DURING INFANT MONITORING. THE MEMORY DOWNLOAD REFLECTS THAT THE UNIT WAS IN USE ON THE REPORTED DATE OF DEATH, RECORDING ALARM CONDITIONS FOR BRADYCARDIA. NO OBSERVATIONS SUBSTANTIATING A MALFUNCTION WERE MADE DURING THE REVIEW OF THE MEMORY DOWNLOAD. THE SMARTMONITOR 2 DEVICE IS NOT INTENDED TO PREVENT LOSS OF BREATHING OR HEART ACTIVITY. THE SMARTMONITOR 2 PARENTS' GUIDE ((B)(4)) 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." THE USER MANUAL STATES THE FOLLOWING USER/OWNER RESPONSIBILITIES. THE RESPIRONICS MONITOR AND ACCESSORIES ARE DESIGNED TO WORK AS DESCRIBED IN THE OPERATOR'S MANUAL. THE USER(S) OF THIS EQUIPMENT SHOULD NOT USE PARTS THAT HAVE FAILED, EXHIBIT EXCESSIVE WEAR, ARE CONTAMINATED, OR OTHERWISE INEFFECTIVE. THE MONITOR AND ITS ACCESSORIES SHOULD NOT BE MODIFIED. THE FOLLOWING LIST INCORPORATES THE OWNER'S RESPONSIBILITIES: PERIODIC CHECK AND MAINTENANCE OF EQUIPMENT; REPLACEMENT OF COMPONENTS AS REQUIRED FOR SAFE AND RELIABLE OPERATION; REPLACEMENT OF INEFFECTIVE PARTS WITH PARTS SUPPLIED BY (B)(4); EQUIPMENT THAT IS NOT FUNCTIONING PROPERLY MUST BE USED UNTIL ALL NECESSARY MAINTENANCE HAS BEEN COMPLETED AND A FACTORY AUTHORIZED SERVICE REP HAS CERTIFIED THE EQUIPMENT AS READY FOR USE; THE MONITOR AND ANY OF ITS ACCESSORIES SHOULD NOT BE MODIFIED; AS A GENERAL RULE, THE PROPER PERFORMANCE OF THE MONITOR SHOULD BE VERIFIED WITH A RESPIRONICS MODEL 5000 SIMULATOR ACCORDING TO THE CHECKOUT PROCEDURE MANUAL #(B)(4) BETWEEN EACH PT USE OR EVERY 6 TO 12 MONTHS OR WHICHEVER IS MORE FREQUENT. THE USER OF THIS EQUIPMENT IS RESPONSIBLE FOR READING, UNDERSTANDING, AND FOLLOWING THE WARNING AND CAUTION STATEMENTS THROUGHOUT THIS MANUAL. ALTHOUGH DEATH WAS REPORTED, THERE WAS NO ALLEGATION OF DEVICE MALFUNCTION. IT HAS BEEN CONCLUDED THAT THE DEVICE DID NOT CAUSE OR CONTRIBUTED TO THE REPORTED INCIDENT. BASED ON ALL AVAILABLE INFO, THE MANUFACTURER CONCLUDES THAT THE DEVICE FUNCTIONS TO SPECIFICATION AND THAT NO FURTHER ACTION IS APPROPRIATE. A FOLLOW-UP REPORT WILL BE FILED IF MORE INFO BECOMES AVAILABLE OR THE DEVICE IS RETURNED FOR THE INVESTIGATION TO THE MANUFACTURER.

    Description of Event or Problem · 1

    CHILDREN'S MEDICAL VENTURES (CHMV) RECEIVED A COMPLAINT REPORT FROM A DURABLE MEDICAL EQUIPMENT (DME) SUPPLIER STATING THAT A PT DEATH HAD OCCURRED ON (B)(6) 2012, WHILE IN THE USE OF A SMARTMONITOR 2 APNEA MONITOR. THE DME REPORTED THAT BASED ON THE DOWNLOAD, THE UNIT DID NOT LOOK AS IF IT WAS NOT ON THE PT UNTIL THE EVENT HAPPENED AND THEN TURNED OFF IMMEDIATELY AFTER. THE MONITOR WAS BROUGHT IN BY THE SHERIFF TO BE DOWNLOADED, BUT REMAINS IN THE CUSTODY OF THE LOCAL LAW AUTHORITY. THE MONITOR WAS SET UP ON THE PT (B)(6) 2012, BUT BASED ON THE DOWNLOAD; THE MONITOR WAS NOT USED CONTINUOUSLY. THERE IS NO ALLEGATION OF PRODUCT MALFUNCTION AND THE UNIT REPORTEDLY ALARMED TO NOTIFY THE CAREGIVER OF A POTENTIAL EVENT. THE MANUFACTURER HAS YET TO RECEIVE THE DEVICE FOR EVAL. HOWEVER, THE APNEA MONITOR'S MEMORY DATA WAS FORWARDED TO CHMV BY THE DME 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SMART MONITOR 2 APNEA MONITOR FLS PHILIPS RESPIRONICS, INC 4002

    Patients

    Seq Age Sex Outcome Treatment
    1 Death