BEUDAMED
    FDA Adverse Event Other Summary report: N

    SMART MONITOR 2

    MDR report key: 2163688 · Received June 16, 2011

    Report

    Report Number
    3007056120-2011-00017
    Event Type
    Other
    Date Received
    June 16, 2011
    Date of Event
    April 28, 2011
    Report Date
    May 19, 2011
    Manufacturer
    PHILIPS RESPIRONICS, INC.
    Product Code
    FLS
    PMA / PMN Number
    K011597
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE AND THE PATIENT DOWNLOAD HAVE NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION AFTER REPEATED ATTEMPTS BY THE MANUFACTURER TO OBTAIN THE DEVICE FROM THE DME. THE SMARTMONITOR 2 DEVICE IS NOT INTENDED TO PREVENT LOSS OF BREATHING OR HEART ACTIVITY. THE SMARTMONITOR 2 PARENTS' GUIDE ((B)(4)) 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. A FOLLOW-UP REPORT WILL BE FILED WHEN THE DEVICE AND PATIENT DOWNLOAD HAS BEEN RETURNED AND AN INVESTIGATION IS COMPLETED BY THE MANUFACTURER.

    Description of Event or Problem · 1

    A DURABLE MEDICAL EQUIPMENT (DME) SUPPLIER REPORTED THAT AN INFANT APNEA MONITOR FAILED TO ALARM DURING AN APNEIC PATIENT EVENT. THE DATE OF THE ALLEGED EVENT WAS ON (B)(6) 2011 AND THE EXACT TIME IS UNKNOWN. THE DME STATED THAT THE CAREGIVER REPORTED THAT THE PATIENT STOPPED BREATHING AND THE MONITOR DID NOT ALARM. CARDIOPULMONARY RESUSCITATION (CPR) WAS PERFORMED AND THE PATIENT WAS SUBSEQUENTLY TAKEN TO THE HOSPITAL. THE DME STATED THAT THE STATUS OF THE BABY IS NOT KNOWN AT THIS TIME.

    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