BEUDAMED
    FDA Adverse Event Other Summary report: N

    SMART MONITOR 2

    MDR report key: 1654373 · Received April 7, 2010

    Report

    Report Number
    2518422-2010-00029
    Event Type
    Other
    Date Received
    April 7, 2010
    Date of Event
    January 1, 2010
    Report Date
    March 8, 2010
    Manufacturer
    PHILIPS RESPIRONICS, INC.
    Product Code
    FLS
    PMA / PMN Number
    K011597
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: DEVICE NOT RETURNED TO MANUFACTURER FOR INVESTIGATION. RESULT: DEVICE WAS EVALUATED BY DME AND DETERMINED TO FUNCTION TO SPECIFICATIONS. THE DEVICE WAS NOT IN USE AT THE TIME OF THE ALLEGED EVENT. CONCLUSION: THE DEVICE WAS EVALUATED BY THE DME ONLY.

    Description of Event or Problem · 1

    A DURABLE MEDICAL EQUIPMENT (DME) SUPPLIER CONTACTED THE MANUFACTURER REPORTING AN ALLEGED EVENT IN WHICH A CAREGIVER REPORTED FINDING HER INFANT APNEIC AND CYANOTIC WITH NO AUDIBLE ALARM FROM THE APNEA MONITOR IN USE ON THE INFANT. THE CAREGIVER REPORTED TAKING THE INFANT TO THE HOSPITAL. THERE WAS NO REPORT OF CARDIOPULMONARY RESUSCITATION (CPR) BEING PERFORMED. THE DME STATED THE INCIDENT OCCURRED "SOMETIME BETWEEN (B)(6) 2010." THE SPECIFIC TIME OF THE EVENT IS UNKNOWN. THE DME RECEIVED THE APNEA MONITOR (A SMARTMONITOR 2) FOR EVALUATION AND DETERMINED THE DEVICE DID NOT MALFUNCTION. THE ALLEGATION THAT THE MONITOR DID NOT ALARM COULD NOT BE CONFIRMED. THE APNEA MONITOR WAS VISUALLY EXAMINED AND TESTED BY THE DME USING A SIMULATOR IN ACCORDANCE WITH THE SMART MONITOR 2 CHECKOUT PROCEDURE MANUAL (PN 1020818). THE APNEA MONITOR DETECTED AND ALARMED APPROPRIATELY FOR SIMULATED EVENTS AND PASSED ALL REQUIRED TESTING. DME DETERMINED THE DEVICE WAS NOT BEING USED AT THE TIME OF EVENT BY DOWNLOAD AND ANALYZING THE INFO RECORDED BY THE APNEA MONITOR. THE DME FURTHER INDICATED THAT THE DEVICE WOULD NOT BE RETURNED FOR ADDITIONAL EVALUATION BY PHILIPS RESPIRONICS AS THE DEVICE PASSED ALL FUNCTIONAL TESTING REQUIRED DURING EVALUATION BY THE DME. THE SMARTMONITOR 2 DEVICE IS NOT INTENDED TO BE USED TO MONITOR PATIENTS FOR CYANOSIS AND HAS NO CAPABILITY TO DO SO. THE SMARTMONITOR 2 PARENTS' GUIDE (PN 572-4000-00) STATES IN THE INDICATIONS FOR USE: THE SMARTMONITOR 2 IS INTENDED FOR USE IN CONTINUOUS MONITORING OF HEART RATE AND RESPIRATION OF INFANT PATIENTS IN A HOME, HOSPITAL OR PORTABLE ENVIRONMENT. ITS PRIMARY FUNCTION IS DETECTION OF CENTRAL APNEA. ITS SECONDARY FUNCTION IS MEASUREMENT OF HEART RATE. 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. THERE WAS NO REPORT OF PERMANENT HARM OR INJURY, AND THE DME WAS NOT ABLE TO CONFIRM THE ALLEGATION OF ALARM FAILURE DURING A PATIENT EVENT. THE DOWNLOAD FROM THE SMARTMONITOR 2 INDICATED THAT THE DEVICE WAS NOT BEING USED ON THE DATE OF THE ALLEGED ADVERSE EVENT. THE MONITOR PASSED ALL REQUIRED TESTING AND DETECTED AND ALARMED APPROPRIATELY FOR SIMULATED EVENTS. BASED ON ALL AVAILABLE INFO, THE MANUFACTURER CONCLUDES THAT THE DEVICE DOES FUNCTION TO SPECIFICATION AND THAT NO FURTHER ACTION IS APPROPRIATE.

    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 Hospitalization| O