BEUDAMED
    FDA Adverse Event Death Summary report: N

    SMART MONITOR 970SE

    MDR report key: 2472034 · Received February 23, 2012

    Report

    Report Number
    3007056120-2012-00004
    Event Type
    Death
    Date Received
    February 23, 2012
    Date of Event
    January 25, 2012
    Report Date
    January 25, 2012
    Manufacturer
    PHILIPS RESPIRONICS, INC.
    Product Code
    NPF
    PMA / PMN Number
    K892006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    A DURABLE MEDICAL EQUIPMENT (DME) SUPPLIER REPORTED THAT AN INFANT PASSED AWAY WHILE USING A SMART MONITOR 970SE INFANT APNEA DEVICE. IT WAS REPORTED THAT "THE CHILD HAD BEEN TO THE DOCTOR AND UPON RETURNING HOME WHEN THE PARENTS WENT TO TAKE THE CHILD OUT OF THE CAR, THEY NOTICED THE CHILD APPEARED LIFELESS." THE EXACT DATE OF THE PT DEATH IS NOT KNOWN AT THIS TIME AND CONFLICTING REPORTS AS TO WHETHER OR NOT THE PT WAS ON THE UNIT AT THE TIME OF THE REPORTED INCIDENT HAVE BEEN RECEIVED. THE PT DOWNLOAD AND THE DEVICE WERE RETURNED TO THE MANUFACTURER FOR EVAL. THE MANUFACTURER IS CURRENTLY INVESTIGATING THE DETAILS INTO THE REPORTED EVENT. A FOLLOW-UP REPORT WILL BE FILED WHEN THE INVESTIGATION IS COMPLETE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SMART MONITOR 970SE APNEA MONITOR NPF PHILIPS RESPIRONICS, INC. 970SE

    Patients

    Seq Age Sex Outcome Treatment
    1 Death