BEUDAMED
    FDA Adverse Event Death Summary report: N

    INTELLIVUE MX700 PATIENT MONITOR

    MDR report key: 7013994 · Received November 9, 2017

    Report

    Report Number
    9610816-2017-00352
    Event Type
    Death
    Date Received
    November 9, 2017
    Date of Event
    October 25, 2017
    Report Date
    October 26, 2017
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    PMA / PMN Number
    K110622
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE CUSTOMER HAD INDICATED THAT ON BED 4425 ON (B)(6) 2017 FROM 22:55 UNTIL 23:35, THERE WAS A GAP WITH NO SPO2 ALARMS. A PHILIPS FIELD SERVICE ENGINEER (FSE) OBTAINED ALARM LOGS AND IMAGES OF THE REVIEW ALARM SCREEN FROM THE CUSTOMER. THE INFORMATION WAS REVIEWED BY A SOFTWARE DEVELOPMENT ENGINEER (SDE), AND CLINICAL SPECIALIST (CS). IT WAS DETERMINED THAT THE SPO2 ALARMS HAD BEEN SHUT-OFF BY A USER AT THE HOSPITAL AT THE BEDSIDE MONITOR AT 22:55; THE ALARMS WERE TURNED ON AT 23:35. IT WAS CONFIRMED THAT THE DEVICE HAD NOT ALARMED, DUE TO A USER SHUTTING-OFF THE ALARMS AT THE BEDSIDE. THIS INFORMATION WAS PROVIDED TO THE CUSTOMER VERBALLY VIA A PHONE CALL ON (B)(6) 2017. THE DEVICE REMAINS AT THE CUSTOMER SITE. THERE WAS NO PRODUCT MALFUNCTION. NO FURTHER INVESTIGATION IS WARRANTED AT THIS TIME.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THERE WAS A PATIENT INCIDENT WITH THE MONITOR NOT ALARMING. THE PATIENT WAS ONLY ON SPO2 MONITORING. A CLINICIAN TURNED OFF THE SP02 ALARMS FOR ABOUT 30 MINS. DURING THAT TIME, THE PATIENT SEVERELY DECOMPENSATED. AFTER THEY CHECKED ON THE PATIENT, AND TURNED THE ALARMS BACK ON, THE CUSTOMER STARTED RESUSCITATION METHODS IMMEDIATELY, BUT WERE UNSUCCESSFUL; THE PATIENT DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    795198 INTELLIVUE MX700 PATIENT MONITOR PATIENT MONITOR MHX PHILIPS MEDICAL SYSTEMS 865241

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Death