BEUDAMED
    FDA Adverse Event Other Summary report: N

    CMS MERLIN MONITOR (FORMERLY HP)

    MDR report key: 560985 · Received December 16, 2004

    Report

    Report Number
    560985
    Event Type
    Other
    Date Received
    December 16, 2004
    Date of Event
    December 5, 2004
    Report Date
    December 16, 2004
    Manufacturer
    PHILIPS MEDICAL SYSTEMS, INC.
    Product Code
    MHX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT MONITOR FAILED TO AUDIBLY ALARM WHEN PATIENT'S SAO2, OXYGEN SATURATION, FELL BELOW LOWER ALARM LIMIT FOR A PERIOD OF 40 MINUTES. THERE WAS NO HARM TO THE PATIENT, WHO REMAINS IN THE HOSPITAL.BIOMEDICAL TESTING: UNIT WAS CONNECTED TO A SIMULATOR. ALL ALARMS FUNCTIONED PROPERLY. NO ERROR CODES IN DEVICE HISTORY. THE ALARMS MAY HAVE BEEN TURNED OFF, SO AN AUTOMATIC FEATURE TO TURN THE ALARMS BACK ON AFTER SOME PERIOD OF TIME MAY BE HELPFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CMS MERLIN MONITOR (FORMERLY HP) PHYSIOLOGICAL MONITOR MHX PHILIPS MEDICAL SYSTEMS, INC. M1094B *
    2 CMS MERLIN (FORMERLY HP) PULSE OXIMETER MODULE DQA PHILIPS MEDICAL SYSTEMS, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 9 DA