BEUDAMED
    FDA Adverse Event Death Summary report: N

    INTELLIVUE MX700 PATIENT MONITOR

    MDR report key: 8700022 · Received June 14, 2019

    Report

    Report Number
    9610816-2019-00156
    Event Type
    Death
    Date Received
    June 14, 2019
    Date of Event
    June 2, 2019
    Report Date
    June 7, 2019
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    PMA / PMN Number
    K110622
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO PRODUCT MALFUNCTION. A PHILIPS RESPONSE CENTER ENGINEER (RCE) OBTAINED ALARM AUDIT LOG FILES THE CENTRAL STATION (PIC IX). THE LOGS SHOW THAT THE ECG ALARMS WERE TURNED DISABLED/OFF AT 00:34 AND THE RESPIRATORY ALARMS WERE TURNED OFF AT 1:50. THESE ALARMS WERE THEN ACTIVATED AT 4:15; ONCE ACTIVATED, ALARMS OCCURRED FOR ASYSTOLE, AND APNEA. THE ALARMS WERE THEN EITHER PAUSED OR SILENCED ON SEVERAL OCCASIONS LEADING UP TO THE EQUIPMENT BEING TAKEN OFFLINE. THE RCE INDICATED THAT THE CUSTOMER BIOMEDICAL ENGINEER (BIOMED) STATED IT IS NOT THE MATERIAL FROM PHILIPS THAT IS THE CAUSE OF THE DEATH, BUT THIS CONFIGURATION CHOICE BY THE SERVICE. THE DEVICE REMAINS AT THE CUSTOMER SITE. NO FURTHER INVESTIGATION IS WARRANTED AT THIS TIME.

    Description of Event or Problem · 1

    THE CUSTOMER WOULD LIKE TO RECOVER THE LOGS FOLLOWING A PATIENT DEATH IN THE NIGHT OF (B)(6) 2019 TO (B)(6) 2019 IN CH6 USINV SERVICE AROUND 3AM. THE PATIENT WAS CONNECTED TO A MX700 BEDSIDE MONITOR. THE PATIENT DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    494654 INTELLIVUE MX700 PATIENT MONITOR PATIENT MONITOR MHX PHILIPS MEDICAL SYSTEMS 865241

    Patients

    Seq Age Sex Outcome Treatment
    1 Death