BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELLIVUE MX40 802.11A/B/G

    MDR report key: 16411741 · Received February 21, 2023

    Report

    Report Number
    1218950-2023-00097
    Event Type
    Malfunction
    Date Received
    February 21, 2023
    Date of Event
    January 25, 2023
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    DSI
    UDI-DI
    00884838030350
    PMA / PMN Number
    K113125
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A PHILIPS CLINICAL APPLICATION SPECIALIST (CAS) WENT TO THE CUSTOMER SITE. THE CAS OBTAINED THE REQUESTED LOGS AND PROVIDED THE PATIENT STRIP. A PHILIPS PRODUCT SUPPORT ENGINEER (PSE) REVIEWED THE LOGS AND PATIENT STRIP. THE PSE CONCLUDED THAT THE MX40 PATIENT WEARABLE MONITOR FUNCTIONING AS DESIGNED. THE STRIP PROVIDED DISPLAYS THAT A MISSED BEAT OCCURRED AT 01:15:44, BECAUSE A BEAT WAS NOT DETECTED WHERE THE ALGORITHM EXPECTED A BEAT TO BE; SUBSEQUENTLY THE ALGORITHM CLASSIFIED 2 P-WAVES AS QUESTIONABLE BEATS. BASED ON THE INFORMATION AVAILABLE, THE MX40 PATIENT WEARABLE MONITOR FUNCTIONING AS DESIGNED.

    Additional Manufacturer Narrative · 0

    PHILIPS IS IN THE PROCESS OF OBTAINING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT AND THE INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 0

    BASED ON THE INFORMATION RECEIVED, THE PATIENT WAS CONSTANTLY MONITORED FROM THE PIIC AND THE NURSE WAS IMMEDIATELY NOTIFIED OF THE ALARM "PM NOT PACING" AND WAS SENT TO CHECK ON THE PATIENT. THERE WAS NO DELAY IN CARE AND NO HARM TO THE PATIENT. IN ADDITION, PER THE PRODUCT SUPPORT ENGINEER, THE CRITERIA FOR AN ASYSTOLE ALARM WAS NOT MET. THE PATIENT WAS TRANSFERRED FROM GENERAL CARDIAC WARD TO CARDIAC CARE UNIT. THE PATIENT INFORMATION CENTER IX IS REPORTED IN MFR 1218950-2023-00098.

    Description of Event or Problem · 0

    IT WAS REPORTED THERE WAS NO ASYSTOLE ALARM FOR A PATIENT WITH AN EXTERNAL PACEMAKER. THE MX40 GENERATED A MISSED BEAT ALARM, BUT DID NOT GENERATE AN ASYSTOLE ALARM AT 4.8 SECONDS OF NO RHYTHM. THE PATIENT WAS TRANSFERRED TO THE CARDIAC CARE UNIT. THE PATIENT INFORMATION CENTER IX IS REPORTED IN MFR1218950-2023-00098.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1667310 INTELLIVUE MX40 802.11A/B/G INTELLIVUE MX40 802.11A/B/G DSI PHILIPS MEDICAL SYSTEMS 865352 00884838030350

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention TINED LEAD, MODEL 1201