BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PHILIPS MEDICAL

    MDR report key: 1362984 · Received April 13, 2009

    Report

    Report Number
    MW5010738
    Event Type
    Malfunction
    Date Received
    April 13, 2009
    Date of Event
    January 7, 2009
    Report Date
    March 26, 2009
    Manufacturer
    PHILIPS ELECTRONICS NORTH AMERICA CORP.
    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 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 PATIENT AND THEREFORE, EFFECTS PATIENT SAFETY. THE HEALTHCARE PROVIDERS NEED ACCESS TO IMMEDIATE WORKING MONITORING OF UNSTABLE PATIENTS THAT ARE BEING CARED FOR IN THE CRITICAL CARE AREAS. THIS IS THE SECOND REPORT ON THIS PIECE OF EQUIPMENT; THIS SAME MACHINE WAS REPORTED WITH THE SAME COMPLAINT ON 01/28/2009. (FIRST CASE OCCURRED IN LATE 2008 & WAS REPORTED 1/28/09.) 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 CORP. M3001A

    Patients

    Seq Age Sex Outcome Treatment
    1