BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMART MONITOR 2

    MDR report key: 2460712 · Received February 13, 2012

    Report

    Report Number
    3007056120-2012-00003
    Event Type
    Malfunction
    Date Received
    February 13, 2012
    Date of Event
    January 14, 2012
    Report Date
    January 14, 2012
    Manufacturer
    PHILIPS RESPIRONICS, INC.
    Product Code
    FLS
    PMA / PMN Number
    K011597
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IT HAS BEEN CONCLUDED THAT 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 SPECIFICATIONS AND THAT NO FURTHER ACTION IS APPROPRIATE.

    Description of Event or Problem · 1

    PHILIPS CHILDREN'S MEDICAL VENTURES (PCHMV) RECEIVED A REPORT FROM A DURABLE MEDICAL EQUIPMENT (DME) SUPPLIER STATING THAT AN INFANT APNEA MONITOR DID NOT ALARM UNDER ANY CIRCUMSTANCE. THE DEVICE WAS REPORTEDLY IN PT USE AT THE TIME. NO PT HARM HAS BEEN REPORTED. THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. QUALITY ASSURANCE DETERMINED THAT THE DEVICE FUNCTIONED TO SPECIFICATIONS. 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 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 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 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."

    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