BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MP50 INTELLIVUE PATIENT MONITOR

    MDR report key: 2062991 · Received March 16, 2011

    Report

    Report Number
    9610816-2011-00145
    Event Type
    Malfunction
    Date Received
    March 16, 2011
    Report Date
    March 1, 2011
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    PMA / PMN Number
    K030038
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTED DESCRIPTION OF THIS COMPLAINT NOTES THERE WAS A PT MONITOR SPEAKER MALFUNCTION. IT WAS CONFIRMED THAT THERE WAS NO AUDIO SENT FROM THE MONITOR'S SPEAKER. IN AN ABUNDANCE OF CAUTION WE WILL REPORT AUDIO LOSS EVEN THOUGH A VISUAL WARNING IS PROVIDED AND PRODUCT LABELING STATES: WARNING - DO NOT RELY EXCLUSIVELY ON THE AUDIBLE ALARM SYSTEM FOR PT MONITORING. ADJUSTMENT OF ALARM VOLUME TO A LOW LEVEL OR OFF DURING PT MONITORING MAY RESULT IN PT DANGER. REMEMBER THAT THE MOST RELIABLE METHOD OF PT MONITORING COMBINES CLOSE PERSONAL SURVEILLANCE WITH CORRECT OPERATION OF MONITORING EQUIPMENT. IN THE PRESENCE OF LIFE-THREATENING EVENTS WHEN NO SOUND IS AVAILABLE FROM THE MONITOR, POSSIBLE SERIOUS INJURY AND/OR DEATH CAN OCCUR. THE MAINBOARD WAS REPLACED TO RESTORE AUDIO FUNCTION. CONSIDERATION OF THIS COMPLAINT AND SIMILAR COMPLAINTS SUPPORT THAT THERE IS NO DESIGN, MANUFACTURING, MATERIALS, OR LABELING PROBLEM. NO FURTHER INVESTIGATION OR ACTION IS WARRANTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED NO AUDIO ON THE MONITOR. NO PT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MP50 INTELLIVUE PATIENT MONITOR MHX PHILIPS MEDICAL SYSTEMS M8004A

    Patients

    Seq Age Sex Outcome Treatment
    1