BEUDAMED
    FDA Adverse Event Death Summary report: N

    SMART MONITOR 2

    MDR report key: 2842601 · Received November 7, 2012

    Report

    Report Number
    3007056120-2012-00022
    Event Type
    Death
    Date Received
    November 7, 2012
    Report Date
    October 8, 2012
    Manufacturer
    PHILIPS RESPIRONICS, INC.
    Product Code
    FLS
    PMA / PMN Number
    K011597
    Removal / Correction Number
    NO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE MANUFACTURER HAS REQUESTED THE DEVICE BE RETURNED FOR EVALUATION. A FOLLOW-UP REPORT WILL BE FILED WHEN THE DEVICE HAS BEEN RETURNED AND EVALUATED BY THE MANUFACTURER.

    Description of Event or Problem · 1

    CHILDREN'S MEDICAL VENTURES (CHMV) RECEIVED A COMPLAINT REPORT FROM A (B)(4) SUPPLIER STATING THAT A PATIENT USING SMARTMONITOR DEVICE WAS TAKEN TO THE HOSPITAL AND PASSED AWAY. THE DEVICE WAS IN PATIENT USE AT THE TIME OF THE REPORTED EVENT. HOWEVER, THERE IS NO ALLEGATION OF DEVICE MALFUNCTION ASSOCIATED WITH THE REPORTED EVENT. NO OTHER ADDITIONAL INFORMATION IS AVAILABLE 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 Death