BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMART MONITOR 2

    MDR report key: 2182611 · Received July 5, 2011

    Report

    Report Number
    3007056120-2011-00018
    Event Type
    Malfunction
    Date Received
    July 5, 2011
    Date of Event
    June 7, 2011
    Report Date
    June 7, 2011
    Manufacturer
    PHILIPS RESPIRONICS, INC.
    Product Code
    FLS
    PMA / PMN Number
    K011597
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    A DURABLE MEDICAL EQUIPMENT (DME) SUPPLIER REPORTED THAT AN INFANT APNEA MONITOR FAILED THE SELF CHECKOUT PROCEDURE AND DID NOT ALARM. THE DEVICE WAS NOT IN PT USE AT THE TIME AND THERE WAS NO DEATH OR SERIOUS INJURY ASSOCIATED WITH THE ALLEGED ALARM FAILURE. THE MFR RECEIVED THE DEVICE FOR EVAL AND CONFIRMED THE DEVICE DID NOT ALARM. THE MFR IS IN THE PROCESS OF COMPLETING ITS INVESTIGATION AND ROOT CAUSE ANALYSIS. A F/U REPORT WILL BE FILED WHEN THE INVESTIGATION IS COMPLETED BY THE MFR.

    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