BEUDAMED
    FDA Adverse Event Other Summary report: N

    SMART MONITOR 2

    MDR report key: 2163687 · Received June 16, 2011

    Report

    Report Number
    3007056120-2011-00016
    Event Type
    Other
    Date Received
    June 16, 2011
    Date of Event
    April 25, 2011
    Report Date
    May 18, 2011
    Manufacturer
    PHILIPS RESPIRONICS, INC.
    Product Code
    FLS
    PMA / PMN Number
    K011597
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, 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 BE USED TO MONITOR PATIENTS FOR CYANOSIS AND HAS NO CAPABILITY TO DO SO. THE SMARTMONITOR 2 PARENTS' GUIDE (PN (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." 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 A (B)(6) APNEA MONITOR FAILED TO ALARM DURING AN APNEIC AND CYANOTIC 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 "BABY WAS TURNING BLUE IN THE CRIB AFTER THE MOM TOOK THE BABY OFF OF OXYGEN." THE FIRE DEPARTMENT WAS CALLED AND ARRIVED TO TREAT THE INFANT. THE BABY DID NOT STOP BREATHING BUT IT WAS NOTICED THAT THE BABY EXPERIENCED OXYGEN DESATURATION. THE BABY 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