BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MX40 1.4 GHZ SMART HOPPING

    MDR report key: 14288443 · Received May 5, 2022

    Report

    Report Number
    1218950-2022-00388
    Event Type
    Injury
    Date Received
    May 5, 2022
    Date of Event
    April 13, 2022
    Manufacturer
    PHILIPS NORTH AMERICA LLC
    Product Code
    DSI
    UDI-DI
    00884838082236
    PMA / PMN Number
    K113125
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 0

    A PHILIPS FIELD SERVICE ENGINEER (FSE) REMOTELY CONNECTED INTO THE CUSTOMER¿S EQUIPMENT AND PULLED THE CLINICAL AUDIT TRAIL LOGS. UPON FURTHER INVESTIGATION, THE FSE FOUND THAT ON APRIL 13, 2022, THE MX40 DEVICE ALARMED ASYSTOLE AND THE ASYSTOLE ALARM WAS ACKNOWLEDGED ON THE MGTELESURV3. ON APRIL 21, 2022, THE FSE VISITED THE SITE. DURING THE VISIT, THE FSE TESTED THE MX40 BY PLACING THE DEVICE INTO A SECTOR AND CONNECTING IT TO A SIMULATOR TO CREATE AN ASYSTOLE EVENT ALARM. THE ASYSTOLE EVENT WAS CREATED AND THE MX40 SUCCESSFULLY ALARMED AS INTENDED. BASED ON THE FOREGOING INVESTIGATION, PHILIPS HEALTHCARE HAS DETERMINED THAT THE ISSUE REPORTED TO US IS NOT CONSISTENT WITH A PRODUCT MALFUNCTION.

    Additional Manufacturer Narrative · 0

    B3: EVENT DATE WAS UPDATED. H6: DEVICE PROBLEM CODE WAS UPDATED. A PHILIPS FIELD SERVICE ENGINEER (FSE) REMOTELY CONNECTED INTO THE CUSTOMER¿S EQUIPMENT AND PULLED THE CLINICAL AUDIT TRAIL LOGS. UPON FURTHER INVESTIGATION, THE FSE FOUND THAT ON (B)(6) 2022, THE MX40 DEVICE ALARMED ASYSTOLE AND THE ASYSTOLE ALARM WAS ACKNOWLEDGED ON THE MGTELESURV3. ON (B)(6) 2022, THE FSE VISITED THE SITE. DURING THE VISIT, THE FSE TESTED THE MX40 BY PLACING THE DEVICE INTO A SECTOR AND CONNECTING IT TO A SIMULATOR TO CREATE AN ASYSTOLE EVENT ALARM. THE ASYSTOLE EVENT WAS CREATED AND THE MX40 SUCCESSFULLY ALARMED AS INTENDED. BASED ON THE FOREGOING INVESTIGATION, PHILIPS HEALTHCARE HAS DETERMINED THAT THE ISSUE REPORTED TO US IS NOT CONSISTENT WITH A PRODUCT MALFUNCTION.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED ON (B)(6) 2022, THE MX40 DEVICE DID NOT ALARM FOR VENTRICULAR FIBRILLATION (VF). PATIENT WENT INTO ASYSTOLE AND CODE BLUE WAS PERFORMED. RESUSCITATION EFFORTS WERE GIVEN AND THE PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT (ICU).

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT ON (B)(6) 2022, THE MX40 DEVICE DID NOT ALARM FOR VENTRICULAR FIBRILLATION (VF). THE PATIENT WENT INTO ASYSTOLE AND CODE BLUE WAS PERFORMED. RESUSCITATION EFFORTS WERE GIVEN AND THE CUSTOMER WAS TRANSFERRED TO THE INTENSIVE CARE UNIT (ICU).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1097846 MX40 1.4 GHZ SMART HOPPING MX40 1.4 GHZ SMART HOPPING DSI PHILIPS NORTH AMERICA LLC 865350 00884838082236

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention| L