BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PHILIPS MALTIPARAMETER PATIENT MONITOR

    MDR report key: 2841418 · Received October 23, 2012

    Report

    Report Number
    1218950-2012-03530
    Event Type
    Malfunction
    Date Received
    October 23, 2012
    Report Date
    October 3, 2012
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    PMA / PMN Number
    K052707
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE CUSTOMER REPORTED THAT THEY WERE RECEIVING A SPEAKER MALFUNCTION INOP MESSAGE ON THE MONITOR AND THERE WAS NO AUDIO. NO PT HARM WAS REPORTED. IN AN ABUNDANCE OF CAUTION, WE WILL REPORT THIS INCIDENT AS THE USER WOULD NOT HEAR THE ALARM AT THE PRIMARY MONITORING SOURCE WHICH MAY LEAD TO A DELAY IN PT CARE. PRODUCT LABELING STATES: WARNING - DO NO RELY EXCLUSIVELY ON THE AUDIBLE ALARM SYSTEM FOR PT MONITORING. THE MOST RELIABLE METHOD OF PT MONITORING REQUIRES CORRECT OPERATION OF THE MONITOR AND CLOSE OBSERVATION OF THE PT. 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 THEY WERE RECEIVING A SPEAKER MALFUNCTION INOP MESSAGE ON THE MONITOR AND THERE WAS NO AUDIO. NO PT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PHILIPS MALTIPARAMETER PATIENT MONITOR MHX PHILIPS MEDICAL SYSTEMS 863074

    Patients

    Seq Age Sex Outcome Treatment
    1