BEUDAMED
    FDA Adverse Event Death Summary report: N

    SMART MONITOR 2

    MDR report key: 2594376 · Received May 24, 2012

    Report

    Report Number
    3007056120-2012-00009
    Event Type
    Death
    Date Received
    May 24, 2012
    Date of Event
    April 21, 2012
    Report Date
    April 25, 2012
    Manufacturer
    PHILIPS RESPIRONICS INC.
    Product Code
    FLS
    PMA / PMN Number
    K011597
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH A DEATH WAS REPORTED, THERE WAS NO ALLEGATION OF DEVICE MALFUNCTION. IT HAS BEEN CONCLUDED THAT THE DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE REPORTED INCIDENT. BASED ON ALL AVAILABLE INFORMATION, THE MANUFACTURER CONCLUDES THAT THE DEVICE FUNCTIONS TO SPECIFICATION AND THAT NO FURTHER ACTION IS APPROPRIATE.

    Description of Event or Problem · 1

    CHILDREN'S MEDICAL VENTURES (CHMV) RECEIVED A COMPLAINT REPORT FROM A (B)(6) SUPPLIER STATING THAT A PATIENT DEATH HAD OCCURRED ON (B)(6) 2012 WHILE IN THE USE OF A SMARTMONITOR 2 APNEA MONITOR. THERE IS NO ALLEGATION OF PRODUCT MALFUNCTION AND THE UNIT REPORTEDLY ALARMED TO NOTIFY THE CAREGIVER OF THE EVENT. THE MANUFACTURER RECEIVED THE DEVICE FOR EVALUATION. THE APNEA MONITOR'S MEMORY DATA WAS DOWNLOADED AND ANALYZED BY TRAINED ASSOCIATES. THE DOWNLOADED MEMORY REVEALED THAT THE DEVICE WAS SET UP WITH PRESCRIBED SETTINGS OF A 20 SECOND DELAY BEFORE ANNUNCIATING AND RECORDING AN ALARM FOR AN APNEA CONDITION. THE SMART MONITOR WAS PROGRAMMED WITH PARAMETERS THAT WERE APPROPRIATE FOR RECORDING AND ALARMING FOR RESPIRATION AND HEART RATE EVENTS DURING INFANT MONITORING. NO OBSERVATION SUBSTANTIATING A MALFUNCTION OR OTHER OPERATION OUTSIDE OF DESIGN SPECIFICATIONS WERE MADE DURING THE EVALUATION. THE UNIT WAS FOUND TO OPERATE AND ALARM WITHIN SPECIFICATIONS. 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. 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 Death