BEUDAMED
    FDA Adverse Event Other Summary report: N

    SMART MONITOR 2

    MDR report key: 2163591 · Received June 2, 2011

    Report

    Report Number
    3007056120-2011-00015
    Event Type
    Other
    Date Received
    June 2, 2011
    Date of Event
    April 28, 2011
    Report Date
    May 6, 2011
    Manufacturer
    PHILIPS RESPIRONICS, INC.
    Product Code
    FLS
    PMA / PMN Number
    K011597
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER RECEIVED THE DEVICE FOR EVALUATION AND IT WAS NOTED THAT THE APNEA ALARM SETTING WAS TURNED OFF. THE APNEA MONITOR WAS VISUALLY EXAMINED AND TESTED BY THE MANUFACTURER 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 TESTING WHEN THE DEVICE WAS PROGRAMMED WITH THE APPROPRIATE MENU SETTINGS. THE APNEA MONITOR'S MEMORY DATA WAS DOWNLOADED AND ANALYZED BY TRAINED ASSOCIATES. THE DOWNLOADED MEMORY REVEALED THE APNEA MONITOR WAS IN USE FROM (B)(6) 2011. ALTHOUGH IT WAS DETERMINED THAT THE ALARM SETTING WAS TURNED OFF, THE DOWNLOAD REVEALED THAT THE MONITOR DETECTED AND ALARMED FOR 6 PATIENT EVENTS FOR APNEA AND BRADYCARDIA CONDITIONS WHILE THE DEVICE WAS IN PATIENT USE. THERE WERE NO PATIENT EVENTS RECORDED AROUND THE TIME OF THE INCIDENT. ALL RECORDED PATIENT EVENTS WERE ASSOCIATED WITH AUDIBLE AND VISUAL ALARMS. BASED ON THE DOWNLOAD IT HAS BEEN DETERMINED THAT THE UNIT HAD CORRECT SETTINGS WHILE IN PATIENT USE AND THE ALARM SETTING WAS CHANGED AFTER THE DEVICE WAS TAKEN OUT OF PATIENT USE AND BEFORE THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. THE SMARTMONITOR 2 WAS RETURNED WITH PRESCRIBED SETTINGS OF A 20 SECOND DELAY BEFORE ANNUNCIATING AND RECORDING AN ALARM FOR AN APNEA CONDITION. THE SMARTMONITOR 2 WAS PROGRAMMED WITH PARAMETERS THAT WERE APPROPRIATE FOR RECORDING AND ALARMING FOR RESPIRATION AND HEART RATE EVENTS DURING INFANT MONITORING. THE SMARTMONITOR 2 PARENTS' GUIDE ((B)(4)) 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 PARENTS' GUIDE ((B)(4)) FURTHER STATES IN THE WARNINGS AND CAUTIONS: "SMARTMONITOR 2 MAY NOT BE ABLE TO DETECT ALL EPISODES OF INADEQUATE BREATHING. IF A BABY HAS APNEA DUE TO CHOKING (OBSTRUCTIVE APNEA), THE MONITOR COULD MISTAKE MOVEMENT CAUSED BY CHOKING FOR BREATHING." THERE WAS NO REPORT OF DEATH OR SERIOUS INJURY, AND THE MANUFACTURER WAS NOT ABLE TO CONFIRM THE ALLEGATION OF ALARM FAILURE DURING A PATIENT EVENT. 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 SPECIFICATION AND THAT NO FURTHER ACTION IS APPROPRIATE.

    Description of Event or Problem · 1

    A DURABLE MEDICAL EQUIPMENT (DME) SUPPLIER REPORTED AN INFANT APNEA MONITOR DID NOT ALARM DURING A PATIENT EVENT. THE EVENT OCCURRED ON (B)(6) 2011 AROUND 10:00PM-11:00PM. IT WAS REPORTED THAT THE CAREGIVER OF THE INFANT NOTICED THE BABY WAS "GURGLING" DUE TO EXCESS MUCUS BUILD-UP IN THE BABY'S THROAT. THE CAREGIVER BULB-SUCTIONED LARGE QUANTITIES OF THICK MUCUS AND PERFORMED "CHEST THRUSTS" TO CLEAR ADDITIONAL OBSTRUCTIONS. THE CAREGIVER STATED THAT THE MONITOR HAD NOT ALARMED WHEN IT SHOULD HAVE BECAUSE "THE CHILD APPEARED TO BE CHOKING AND MAY HAVE HAD A CHEST WALL MOVEMENT." AN AMBULANCE WAS CALLED AND THE BABY WAS SUBSEQUENTLY TAKEN TO THE HOSPITAL FOR OBSERVATION. NO DEATH OR SERIOUS INJURY RESULTED.

    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 Hospitalization