BEUDAMED
    FDA Adverse Event Death Summary report: N

    MX40 1.4 GHZ SMART HOPPING

    MDR report key: 13578399 · Received February 22, 2022

    Report

    Report Number
    1218950-2022-00147
    Event Type
    Death
    Date Received
    February 22, 2022
    Date of Event
    January 20, 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
    IL, 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 FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 0

    SECTION B EVENT DATE WAS CORRECTED. PHILIPS HEALTHCARE INVESTIGATED THE ISSUE. THE AUDIT LOGS WERE PULLED AND PROVIDED TO PHILIPS BY THE FIELD SERVICE ENGINEER (FSE) AND WERE REVIEWED BY THE PHILIPS TELEMETRY PRODUCT SUPPORT ENGINEER (PSE). BASED ON THE LOG REVIEW, THERE WERE NO SPO2 DESAT ALARMS PROVIDED IN THE INCIDENT TIMEFRAME. THERE WERE SEVERAL SPO2T NO PULSE AND SPO2T NOISYSIGNAL INOP ALARMS THROUGHOUT THE INCIDENT TIMEFRAME. SPO2T NO PULSE INOP INDICATES THE PULSE IS TOO WEAK OR NOT DETECTABLE. THE SPO2T NOISYSIGNAL INOP INDICATES THERE IS EXCESSIVE PATIENT MOVEMENT OR ELECTRICAL INTERFERENCE CAUSING IRREGULAR PULSE PATTERNS. THE NOTED SPO2 INOPS ARE INTENDED TO ALERT USERS TO ISSUES THAT PREVENT THE SPO2 MEASUREMENT FROM BEING CALCULATED. THERE WERE ECG LIMIT VIOLATION ALARMS (**YELLOW), VTACH (***RED), AND ASYSTOLE (***RED) PROVIDED AS THE PATIENT¿S CONDITION CHANGED/DETERIORATED. THE RFDA LOG DOES NOT REVEAL ANY LOSSES OF COMMUNICATION BETWEEN THE MX40 AND NETWORK/PIC IX DURING THE INCIDENT TIMEFRAME. 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

    IT WAS REPORTED THAT THE PATIENT MONITOR FAILED TO ALARM FOR LOW SPO2 / OXYGEN DESATURATION FOR APPROXIMATELY TEN MINUTES. IT WAS FURTHER REPORTED THAT THE PATIENT SUBSEQUENTLY EXPERIENCED VENTRICULAR TACHYCARDIA (V-TACH) AND EXPIRED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT MONITOR FAILED TO ALARM FOR LOW SPO2 / OXYGEN DESATURATION FOR APPROXIMATELY TEN MINUTES. IT WAS FURTHER REPORTED THAT THE PATIENT SUBSEQUENTLY EXPERIENCED VENTRICULAR TACHYCARDIA (V-TACH) AND EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1146962 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 Unknown Death