BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMARTMONITOR 2 APNEA MONITOR

    MDR report key: 1834106 · Received August 26, 2010

    Report

    Report Number
    1834106
    Event Type
    Malfunction
    Date Received
    August 26, 2010
    Date of Event
    August 23, 2010
    Report Date
    August 26, 2010
    Manufacturer
    PHILIPS RESPIRONICS
    Product Code
    BZQ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    CHILD IN INFANT SEAT TURNED BLUE AND THE APNEA MONITOR DID NOT ALARM. WITNESSED BY PARENT, CHILD WAS REMOVED FROM SEAT AND COLOR IMPROVED AND CHILD WAS BREATHING WITH NORMAL RESPIRATIONS. THE MONITOR WAS RUNNING ON BATTERY POWER AT THE TIME. HOME HEALTH RESPIRATORY THERAPIST CAME TO THE HOME AFTER THE INCIDENT WAS REPORTED AND CHECKED THE MACHINE AND IT APPEARED TO BE WORKING. IT WAS REMOVED FROM THE HOME AND REPLACED WITH ANOTHER MACHINE. IT HAS BEEN SENT TO OUR CLINICAL ENGINEERING DEPARTMENT FOR EVALUATION.====================== HEALTH PROFESSIONAL'S IMPRESSION======================UNSURE, RESPIRATORY THERAPIST WAS CALLED TO THE HOME AFTER THE EVENT AND THE MONITOR APPEARED TO BE WORKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SMARTMONITOR 2 APNEA MONITOR MONITOR, BREATHING FREQUENCY BZQ PHILIPS RESPIRONICS * *

    Patients

    Seq Age Sex Outcome Treatment
    1 * NO OTHER THERAPIES