BEUDAMED
    FDA Adverse Event Death Summary report: N

    MX40 1.4 GHZ SMART HOPPING

    MDR report key: 10591220 · Received September 27, 2020

    Report

    Report Number
    1218950-2020-05685
    Event Type
    Death
    Date Received
    September 27, 2020
    Date of Event
    September 20, 2020
    Report Date
    September 23, 2020
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    DSI
    PMA / PMN Number
    K113125
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    A PHILIPS FIELD SERVICE ENGINEER (FSE) REVIEWED THE CUSTOMER'S EXPERIENCE AND ADVISED THE HOSPITAL'S BIOMED THAT "THERE IS NO ALARM FUNCTION FOR PULSE RATE." PHYSIOLOGICAL ALARMS FOR PULSE RATE IS NOT AVAILABLE WITH THE CURRENT SOFTWARE REVISION THAT THIS MX40 HAS. THE FSE OBTAINED THE AUDIT LOG FROM THE HOSPITAL. OUR PHILIPS PRODUCT SUPPORT ENGINEER (PSE) REVIEWED THE AUDIT LOG AND THE REPORTED INCIDENT DETAILS. THE PSE FOUND THE FSE¿S ASSESSMENT TO BE ACCURATE. HE CONFIRMED THAT THIS DEVICE IS OPERATING ON SOFTWARE REVISION B.06.59. PHYSIOLOGICAL ALARMS FOR THE PULSE PARAMETER IS NOT AVAILABLE FOR MX40¿S WITH SOFTWARE REVISIONS B.06.59 AND LOWER. THE PSE ADVISED THERE ARE TECHNICAL INOPS AVAILABLE AS NOTED BY THE CM WHO INDICATED THEY RECEIVED, ¿SPO2T NO PULSE,¿ INOP. THIS MESSAGE IS TO ALERT USERS OF AN ISSUE WITH THE MEASUREMENT. THE PSE CONFIRMED AN INOP SOUND FOR A ¿SPO2T NO PULSE¿ INOP EVENT IS PLAYED AT THE PIIC AND THE INOP LABEL WILL BE DISPLAYED IN THE PATIENT SECTOR. THE INOP LABEL FOR ¿SPO2T NO PULSE¿ WOULD NOT BE CAPTURED IN THE AUDIT LOG. BASED ON OUR INVESTIGATION, THE MX40 WAS PERFORMING AS DESIGNED. 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 HOSPITAL'S CLINICAL MANAGER (CM) REPORTED TO THE HOSPITAL'S BIOMED THAT A PATIENT DEATH OCCURRED ON (B)(6) 2020 AT AROUND 7:54 AM, WHEN THE PATIENT WITH AN INTERNAL PACEMAKER WAS BEING MONITORED UTILIZING THE PULSE OXIMETER FUNCTION OF THE MX40. THE CM STATED THEY BELIEVED THERE SHOULD HAVE BEEN A PATIENT PHYSIOLOGICAL ALARM WHEN THE PLETH ON THE PULSE OXIMETER DISPLAYED THE TECHNICAL INOP ALARM, "NO PULSE" WHICH OCCURRED AT 0754; HOWEVER, THERE WAS NO PATIENT PHYSIOLOGICAL ALARM NOTED FOR IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1055688 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