BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELLIVUE INFORMATION CENTER IX

    MDR report key: 10240112 · Received July 7, 2020

    Report

    Report Number
    1218950-2020-03904
    Event Type
    Malfunction
    Date Received
    July 7, 2020
    Report Date
    June 23, 2020
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    UDI-DI
    00884838093041
    PMA / PMN Number
    K102495
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H10: SERVICE BULLETIN (B)(4) WAS RELEASED 16JUN2020 WHICH STATED THAT CUSTOMERS WHO ARE USING MX40 RUNNING C.01.31 SOFTWARE WITH PIC IX C.03.01 OR LOWER SOFTWARE DO NOT HAVE THE ABILITY TO ADJUST THE MINIMUM QRS DETECTION THRESHOLD. THIS COMBINATION OF MX40 AND PIC IX SOFTWARE MAY CAUSE AN INCREASE IN FALSE ECG ALARMS DUE TO THE FIXED HIGHER DEFAULT THRESHOLD (300 MICROVOLTS). THIS CHANGE TO THE MINIMUM QRS DETECTION THRESHOLD WAS CREATED AS AN ENHANCEMENT AND NOT A MANDATORY ACTION. 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

    PHONE NOT FORMATTED FOR TRANSMISSION: (B)(6). A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED PROBLEMS WITH ASYSTOLE ALARMS OCCURRING AT THEIR PHILIPS INTELLIVUE INFORMATION CENTER (PIIC). THE DEVICE WAS IN USE ON A PATIENT. THERE WAS NO REPORT OF PATIENT OR USER HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    707196 INTELLIVUE INFORMATION CENTER IX CENTRAL STATION MONITOR MHX PHILIPS MEDICAL SYSTEMS 866389 00884838093041

    Patients

    Seq Age Sex Outcome Treatment
    1