BEUDAMED
    FDA Adverse Event Death Summary report: N

    MX40 1.4 GHZ SMART HOPPING

    MDR report key: 10844065 · Received November 16, 2020

    Report

    Report Number
    1218950-2020-06892
    Event Type
    Death
    Date Received
    November 16, 2020
    Date of Event
    November 3, 2020
    Report Date
    November 4, 2020
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    DSI
    PMA / PMN Number
    K113125
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    A PHILIPS FIELD SERVICE ENGINEER (FSE) PROVIDED THE ALARM AUDIT LOG, THE RFDA LOG ,AND DEVICE DEBUG LOG FROM THE HOSPITAL SITE. THE FSE ALSO INSPECTED THE DEVICE WHILE AT THE HOSPITAL SITE. THE FSE WAS PROVIDED A 10 SECOND CAPTURE OF THE ELECTROCARDIOGRAPH REPORT (STRIP) BY THE HOSPITAL. OUR PHILIPS PRODUCT SUPPORT ENGINEER (PSE) REVIEWED THE ALARM AUDIT LOG, RFDA LOG, DEVICE DEBUG LOG, AND STRIP. PHILIPS DETERMINED THE MX40 ALARMED APPROPRIATELY AS THE ALARM LOGS FOR THE DATE AND TIME OF THE INCIDENT SHOWS HEART RATE RELATED ALARMS AND ALARMS BEING ACKNOWLEDGED. THIS INVESTIGATION WAS PROVIDED TO THE CUSTOMER. THE DEVICE REMAINS AT THE HOSPITAL SITE. 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 ON (B)(6) 2020 AT 11:45 AM, A PATIENT CODED AND THE DEVICE DID NOT ALARM. THE CODE RESULTED IN PATIENT DEATH. THE CUSTOMER STATED THERE WAS AN ARTIFACT ON 2 & 3 BUT THEY DIDN'T CHECK ANY OTHER LEAD SETS. THE DEVICE WAS REMOVED FROM SERVICE BY THE BIOMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1309404 MX40 1.4 GHZ SMART HOPPING MX40 1.4 GHZ SMART HOPPING DSI PHILIPS MEDICAL SYSTEMS 865350

    Patients

    Seq Age Sex Outcome Treatment
    1 Death