BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MP20 INTELLIVUE PATIENT MONITOR

    MDR report key: 1874415 · Received October 12, 2010

    Report

    Report Number
    9610816-2010-00594
    Event Type
    Malfunction
    Date Received
    October 12, 2010
    Report Date
    September 21, 2010
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    PMA / PMN Number
    K030038
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT IS DEEMED REPORTABLE SINCE PHILIPS DOES NOT HAVE ENOUGH DATA TO VERIFY THAT THERE WAS NO SOUND COMING FROM THE SPEAKER. IN AN ABUNDANCE OF CAUTION, WE WILL REPORT THIS INCIDENT ALTHOUGH IN THIS CASE, THE ALARMS WOULD STILL BE ANNUNCIATED AT THE CENTRAL STATION. 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. PHILIPS IS IN THE PROCESS OF OBTAINING ADDITIONAL INFO 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 THAT HIS MP20 HAS A SPEAKER MALFUNCTION ERROR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MP20 INTELLIVUE PATIENT MONITOR MHX PHILIPS MEDICAL SYSTEMS M8001A

    Patients

    Seq Age Sex Outcome Treatment
    1