BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PHILIPS MEDICAL

    MDR report key: 1305996 · Received February 5, 2009

    Report

    Report Number
    MW5009873
    Event Type
    Malfunction
    Date Received
    February 5, 2009
    Date of Event
    December 11, 2008
    Report Date
    January 28, 2009
    Manufacturer
    PHILIPS ELECTRONICS NORTH AMERICA CORPORATION
    Product Code
    MHX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE MMS (MULTI MEASUREMENT SERVER) MODULE WAS INTERMITTENTLY CONNECTING AND DISCONNECTING. WHEN THE MODULE EXHIBITS THIS SYMPTOM, IT REQUIRES THE TIME OF THE HEALTHCARE PROVIDER TO ADDRESS THE ISSUE AND TAKE STEPS TO GET A DIFFERENT WORKING MODULE WHICH IS TIME LOST TAKING CARE OF THE CRITICALLY ILL PT AND THEREFORE EFFECTS PT SAFETY. THE HEALTHCARE PROVIDERS NEED ACCESS TO IMMEDIATE WORKING MONITORING OF UNSTABLE PATIENTS THAT ARE BEING CARED FOR IN THE CRITICAL CARE AREAS. THE BIOMEDICAL TECHNICIAN REPLACED THE NECESSARY COMPONENTS, TESTED THE DEVICE, AND RETURNED IT TO SERVICE. THE DEVICE IS AVAILABLE FOR ONSITE EVALUATION AT OUR FACILITY. QUESTIONS AND COMMENTS SHOULD BE DIRECTED TO THE BIOMEDICAL DIRECTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PHILIPS MEDICAL MMS (MULTI MEASUREMENT SERVER) MODULE MHX PHILIPS ELECTRONICS NORTH AMERICA CORPORATION M3001A

    Patients

    Seq Age Sex Outcome Treatment
    1