BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MX40 2.4 GHZ SMART HOPPING

    MDR report key: 11074013 · Received December 27, 2020

    Report

    Report Number
    1218950-2020-08088
    Event Type
    Injury
    Date Received
    December 27, 2020
    Date of Event
    December 18, 2020
    Report Date
    December 18, 2020
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    DSI
    PMA / PMN Number
    K113125
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H10:A PHILIPS REMOTE SERVICE ENGINEER (RSE) TALKED TO THE CUSTOMER IN ORDER TO TROUBLESHOOT THE ISSUE. THE RSE CONFIRMED THE REPORTED ISSUE AND FOUND THAT IT HAD OCCURRED DUE TO THE MX40'S BATTERY LEVELS. THE MX40 HAD DIED WHICH RESULTED IN NO DATA BEING SENT TO THE PIC IX. THE PRODUCT SUPPORT ENGINEER (PSE) REVIEWED THE LOGS AND CONFIRMED THERE WERE NO ALARMS DURING THE TIMEFRAME OF THE INCIDENT IN THE AUDIT LOGS BECAUSE THE MX40 HAD BEEN OFFLINE SINCE 10:59 AM. (B)(6) 2020 AT 00:34:51 THERE WAS AN INOP, TELE-BATTERY: MAINTENANCE GENERATED AT 00:34:50. THIS INOP IS GENERATED WHEN THE MX40 RECHARGEABLE LIION BATTERY HAS EXCEEDED 500 COMPLETE CHARGE/DISCHARGE CYCLES. THIS ALSO CORRELATES TO THE BOOT UP INFORMATION FROM THE DEVICE DEBUG LOG THAT SHOWS THE BATTERY VOLTAGE AT 3997MV (3997 MILLIVOLTS OR 3.9VOLTS). THIS INDICATES REDUCED CAPACITY OF THE BATTERY. THE MX40 CONNECTION TO THE PIC WAS LOST AT 10:59:05 ON 18DEC2020. UPON REPLACEMENT OF THE BATTERY, THE DEVICE BOOTED UP AND ESTABLISHED CONNECTION WITH THE PIC AT 15:14:32 ON 18DEC2020. THERE WAS NO MALFUNCTION OF THE MX40 TELEMETRY DEVICE. THE DEVICE REMAINS IN USE AT THE CUSTOMER'S SITE AND NO SUBSEQUENT CALLS HAVE BEEN RECEIVED REGARDING THIS ISSUE. 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. DURING A CALL WITH THE CUSTOMER REGARDING THIS EVENT, THE CUSTOMER REPORTED THEY PUT A NEW BATTERY IN THE MX40 DEVICE AND IT CONNECTED TO THE PIIC IX. 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.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE PATIENT HAD TO BE RESUSCITATED (B)(6) 2020 AT APPROXIMATELY 01:00 PM. THE NURSE WAS IN THE PATIENT'S ROOM WHEN THE EVENT OCCURRED. THE CUSTOMER REPORTED THE MX40 WAS NOT WORKING AT THE TIME OF THE EVENT AND THE USERS WERE UNABLE TO FIND DATA FOR THE INCIDENT IN THE PATIENT INFORMATION CENTER (PIIC IX). THE PATIENT WAS TRANSFERRED TO THE ICU.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1538472 MX40 2.4 GHZ SMART HOPPING MX40 2.4 GHZ SMART HOPPING DSI PHILIPS MEDICAL SYSTEMS 865351

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening