BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELLIVUE MULTI MEASUREMENT SERVER X2

    MDR report key: 2272563 · Received September 21, 2011

    Report

    Report Number
    9610816-2011-00552
    Event Type
    Malfunction
    Date Received
    September 21, 2011
    Report Date
    September 13, 2011
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    PMA / PMN Number
    K071426
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED A SPEAKER MALFUNCTION. NO LOSS OF AUDIO WAS INITIALLY REPORTED. NO PATIENT HARM WAS REPORTED. IN AN ABUNDANCE OF CAUTION WE WILL REPORT POSSIBLE AUDIO LOSS EVEN THOUGH A VISUAL WARNING IS PROVIDED AND PRODUCT LABELING STATES: WARNING: DO NOT RELY EXCLUSIVELY ON THE AUDIBLE ALARM SYSTEM FOR PATIENT MONITORING. ADJUSTMENT OF ALARM VOLUME TO A LOW LEVEL OR OFF DURING PATIENT MONITORING MAY RESULT IN PATIENT DANGER. REMEMBER THAT THE MOST RELIABLE METHOD OF PATIENT MONITORING COMBINES CLOSE PERSONAL SURVEILLANCE WITH CORRECT OPERATION OF MONITORING EQUIPMENT. PHILIPS IS IN THE PROCESS OF OBTAINING ADDITIONAL INFORMATION REGARDING THIS INCIDENT AND THE COMPLAINT IS STILL UNDER INVESTIGATION. A FINAL REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A SPEAKER MALFUNCTION AND RECEIVING AN ERROR MESSAGE. NO PATIENT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTELLIVUE MULTI MEASUREMENT SERVER X2 MHX PHILIPS MEDICAL SYSTEMS M3002A

    Patients

    Seq Age Sex Outcome Treatment
    1