BEUDAMED
    FDA Adverse Event Death Summary report: N

    INTELLIVUE MX500 PATIENT MONITOR

    MDR report key: 18260511 · Received December 4, 2023

    Report

    Report Number
    9610816-2023-00642
    Event Type
    Death
    Date Received
    December 4, 2023
    Date of Event
    October 3, 2023
    Manufacturer
    PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH
    Product Code
    MHX
    UDI-DI
    00884838038776
    PMA / PMN Number
    K131872
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE ALLEGED TIME OF THE EVENT WAS BETWEEN 12:30 AND 15:30 HOURS AND NEW INFORMATION WAS PROVIDED THAT THE EVENT RESULTED IN THE PATIENT DEATH. THE COMPLAINT WAS ESCALATED FOR TECHNICAL INVESTIGATION, AND THE CLINICAL AUDIT LOGS SHOW THAT THE LAST HR ALARM (HR 206>200) WAS GENERATED AT 15:13:03 AND TERMINATED A FEW SECONDS LATER. AFTER THAT, THERE WERE SEVERAL INOPS RELATED TO ECG / RESPIRATORY LEAD OFF, WHICH MAY INDICATE POOR ELECTRODE CONTACT TO THE SKIN. NOISY ECG WAS ALSO SHOWN IN THE LOGS, WHICH MEANS THAT ECG COULD NOT BE ANALYZED. FROM 15:13 UNTIL 17:39, THERE WERE NO ECG RELATED ALERTS IN THE CLINICAL AUDIT TRAIL. THE CLINICAL AUDIT LOGS ALSO INDICATE THAT THERE WERE ALARMS FOR EXCEEDING THE LOW HR LIMIT. BASED ON THE INFORMATION AVAILABLE AND THE TESTING CONDUCTED, THE DEVICE WAS FUNCTIONING AS INTENDED AND THERE WAS NO TROUBLE FOUND WITH THE DEVICE. THE REPORTED PROBLEM WAS NOT CONFIRMED. CORRECTED INFORMATION: OUTCOMES ATTRIBUTED TO AE IS UPDATED TO DEATH, 510K: K131872, A4 PATIENT WEIGHT: 4 KG, F3: USER FACILITY: (B)(4), D1: INTELLIVUE MX500 PATIENT MONITOR, H1 TYPE OF REPORTED COMPLAINT IS UPDATED TO DEATH, D2A: INTELLIVUE MX500 PATIENT MONITOR, D4: MODEL#: 866064, D4 CATALOG#: 866064, D4 SERIAL#: (B)(6), D4 UNIQUE IDENTIFIER: (B)(4).

    Additional Manufacturer Narrative · 0

    PHILIPS IS IN THE PROCESS OF OBTAINING ADDITIONAL INFORMATION CONCERNING THIS EVENT AND THE COMPLAINT IS STILL UNDER INVESTIGATION. A FINAL REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 0

    IT WAS REPORTED ON (B)(6) 2023, THERE WAS A FAILURE TO ALARM FOR BRADYCARDIA AT THE CENTRAL STATION AND THE BEDSIDE MONITOR. THE DEVICE WAS IN USE AND THE MONITOR DISPLAYED A HEART RATE OF 54 BPM, WHICH WAS OUTSIDE THE SET PARAMETERS (HIGH LIMIT-200 BPM AND LOW LIMIT-100 BPM). IT WAS INDICATED THE BRADYCARDIA WAS NOT MANAGED IN TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2064705 INTELLIVUE MX500 PATIENT MONITOR INTELLIVUE MX500 PATIENT MONITOR MHX PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH 866064 00884838038776

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death| L