BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MX40 1.4 GHZ SMART HOPPING

    MDR report key: 11848160 · Received May 19, 2021

    Report

    Report Number
    1218950-2021-10561
    Event Type
    Injury
    Date Received
    May 19, 2021
    Date of Event
    April 20, 2021
    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
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    THE PHILIPS FIELD SERVICE ENGINEER (FSE) SECURED LOG FILES TO INCLUDE INTELLIVUE INFORMATION CENTER (PIIC) AUDIT LOGS AS WELL AS MX40 LOGS. WHILE ONSITE, THE FSE PERFORMED TESTS AND CHECKED BEHAVIOR AND LEADSET UNPLUGGED RESPONSE. THE FSE NOTED A PREVIOUSLY CONFIGURED BLUE INOP SECTOR ALERT AND CHANGED THE INOP SEVERITY TO YELLOW. ACCORDING TO THE FSE, THE MX40 IS WORKING AS INTENDED. OUR PHILIPS PRODUCT SUPPORT ENGINEER (PSE) REVIEWED AND PROVIDED AN ASSESSMENT OF THE PIIC AND MX40 LOG DATA PROVIDED BY THE FSE. ACCORDING TO THE PSE, THE MX40 LOGS WERE INCOMPLETE AND DID NOT CONTAIN THE PWM LOG DATA. THE AUDIT LOG .XML FILE CONTAINED INFORMATION FOR THE INCIDENT TIMEFRAME AND SHOWS ALARMS RELATED TO SPO2T NO SENSOR, LA LEAD OFF, ECG LEADS OFF, RESSP LEAD OFF JUST PRIOR TO THE ¿LEADSET UNPLUGGED¿ INOP WHICH WAS GENERATED AT 08:36:31 ON (B)(6) 2021. ACCORDING TO THE PSE, THE ¿LEADSET UNPLUGGED¿ INOP WAS NOT ACKNOWLEDGED (BY A USER) UNTIL 12:11:59 ON(B)(6) 2021. MOREOVER, THE ¿SPO2T NO SENSOR¿ AND ¿LEADSET UNPLUGGED¿ INOPS WOULD HAVE BEEN DISPLAYED AT THE PATIENT SECTOR UNTIL THE TIME THEY WERE ACKNOWLEDGED (SILENCED) BY A USER. BASED ON PHILIPS¿ REVIEW OF THE LOGS, THE DEVICES WERE DETERMINED TO BE WORKING AS DESIGNED. THE INVESTIGATION WAS PROVIDED TO THE REPORTER. THE DEVICE REMAINS AT THE CUSTOMER SITE.

    Description of Event or Problem · 0

    A NURSE MANAGER REPORTED THAT ON (B)(6) 2021 FROM APPROXIMATELY 8:30AM-12:42PM, THERE APPEARED TO BE NO ECG DATA. THE LEADSET UNPLUGGED CONDITION LASTED FOR GREATER THAN 3 HOURS. WHEN THE PATIENT WAS RECONNECTED, RESUSCITATION WAS NECESSARY.

    Description of Event or Problem · 1

    A NURSE MANAGER REPORTED THAT ON (B)(6) 2021 FROM APPROXIMATELY 8:30AM-12:42PM, THERE APPEARED TO BE NO ECG DATA. THE LEADSET UNPLUGGED CONDITION LASTED FOR GREATER THAN 3 HOURS. WHEN THE PATIENT WAS RECONNECTED, RESUSCITATION WAS NECESSARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    745858 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 Hospitalization