BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELLIVUE MX700 PATIENT MONITOR

    MDR report key: 8077158 · Received November 16, 2018

    Report

    Report Number
    9610816-2018-00316
    Event Type
    Malfunction
    Date Received
    November 16, 2018
    Report Date
    November 5, 2018
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    UDI-DI
    00884838029088
    PMA / PMN Number
    K110622
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    SUBMISSION OF A REPORT DOES NOT CONSTITUTE AN ADMISSION THAT MEDICAL PERSONNEL, USER FACILITY, IMPORTER, DISTRIBUTOR, MANUFACTURER, OR PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.

    Additional Manufacturer Narrative · 1

    A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE MONITOR DOESN'T ALARM AUDIBLY FOR VTACHY, BUT AT THE CENTRAL STATION (PIIC IX) A STRIP IS CONTAINED IN ALARM REVIEW. THERE WAS NO ADVERSE EVENT OF PATIENT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    916325 INTELLIVUE MX700 PATIENT MONITOR PATIENT MONITOR MHX PHILIPS MEDICAL SYSTEMS 865241 00884838029088

    Patients

    Seq Age Sex Outcome Treatment
    1