BEUDAMED
    FDA Adverse Event Death Summary report: N

    CARESCAPE B650

    MDR report key: 23849803 · Received December 19, 2025

    Report

    Report Number
    3008729547-2025-00106
    Event Type
    Death
    Date Received
    December 19, 2025
    Date of Event
    November 20, 2025
    Report Date
    March 11, 2026
    Manufacturer
    CRITIKON DE MEXICO S. DE R.L. DE C.V.
    Product Code
    MHX
    UDI-DI
    00840682105200
    PMA / PMN Number
    K131223
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    LEGAL MANUFACTURER: GEHC TROUT, 3114 N GRANDVIEW BLVD. WAUKESHA, WI 53188 USA. GE HEALTHCARE'S INVESTIGATION IS IN-PROGRESS. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED.

    Additional Manufacturer Narrative · 0

    GE HEALTHCARE HAS COMPLETED ITS INVESTIGATION. ENGINEERING REVIEWED THE MONITOR LOG FILES AND FOUND THAT MULTIPLE ALARMS WERE PROVIDED FOR THE EVENT. A MEDIUM-PRIORITY BRADY ALARM WAS ASSERTED FOLLOWED BY A LEADS OFF CONDITION ALARM (ALSO AS MEDIUM-PRIORITY LEVEL). AT MEDIUM-PRIORITY, THE MONITOR PROVIDES BOTH VISUAL AND AUDIBLE NOTIFICATIONS. THE LEADS OFF ALARM IS GIVEN WHEN THE ECG ELECTRODES OR LEADS ARE DETECTED AS DISCONNECTED FROM THE PATIENT. IT IS INTENDED TO ALERT THE USER AND PROMPT THE APPROPRIATE TROUBLESHOOTING MEASURES. THE LOGS SHOWED THAT ONCE ECG LEADS CONNECTION WAS RESTORED, THE MONITOR ASSERTED MULTIPLE ASYSTOLE ALARMS WHICH WERE ACKNOWLEDGED BY THE USERS. THE GE HEALTHCARE FIELD ENGINEER TESTED THE DEVICE WITH A SIMULATOR AND CONFIRMED IT WAS ALARMING AS SPECIFIED. IN A REVIEW OF HISTORICAL DATA, NO ADVERSE TRENDS WERE IDENTIFIED. BASED ON THE INFORMATION AVAILABLE, THE INVESTIGATION CONCLUDED THAT THE MONITOR WAS WORKING AS DESIGNED. THE RISK ANALYSIS DETERMINED THAT NO ADDITIONAL MITIGATIONS ARE AVAILABLE TO REDUCE THE RISK, AND THE RISK HAS BEEN REDUCED AS FAR AS POSSIBLE. NO FURTHER ACTIONS ARE PLANNED BY GE HEALTHCARE.

    Description of Event or Problem · 0

    A PATIENT WAS BEING MONITORED WITH THE CARESCAPE B650 WHEN IT WAS REPORTED THAT THE PATIENT WAS FOUND IN ASYSTOLE, BUT THE DEVICE WAS NOT ALARMING AS EXPECTED. THE PATIENT DID NOT SURVIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2423885 CARESCAPE B650 MONITOR, PHYSIOLOGICAL, PATIENT MHX CRITIKON DE MEXICO S. DE R.L. DE C.V. 00840682105200

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death