BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE NXT RESUSCITATION SYSTEM

    MDR report key: 23985054 · Received January 6, 2026

    Report

    Report Number
    3010617000-2026-00007
    Event Type
    Malfunction
    Date Received
    January 6, 2026
    Date of Event
    December 9, 2025
    Report Date
    January 6, 2026
    Manufacturer
    ZOLL CIRCULATION, INC.
    Product Code
    DRM
    UDI-DI
    00849111003384
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    FOR G4: PMA/510(K): PREMARKET SUBMISSION NUMBER NOT AVAILABLE/NOT RELEASED. THE CUSTOMER'S COMPLAINT THAT THE AUTOPULSE NXT PLATFORM (SN (B)(6) OVERHEATED AFTER COMPRESSIONS WAS NOT CONFIRMED DURING THE FUNCTIONAL TESTING. NO DEVICE MALFUNCTION WAS OBSERVED DURING THE TESTING, AND THE NXT PLATFORM FUNCTIONED AS INTENDED. BASED ON THE ARCHIVE LOG REVIEW, THE PLATFORM WAS USED FOR A 21-MINUTE, 49-SECOND TREATMENT SESSION ON NOVEMBER 18, DURING WHICH 1,758 COMPRESSIONS WERE DELIVERED. THIS DATE IS LIKELY WHEN THE PROBLEM OCCURRED. THE SESSION ENDED DUE TO A LOW BATTERY VOLTAGE, INDICATED BY FAULT 1160 (FAULT_VPACK_LOW_BATT_VOLT): LOW BATTERY VOLTAGE DETECTED, COMPRESSIONS STOPPED. WITHIN TWO MINUTES, THE USER REPLACED THE DEPLETED BATTERY WITH A FULLY CHARGED ONE. THE PLATFORM WAS THEN USED FOR ANOTHER TREATMENT SESSION, WHICH CONCLUDED WHEN THE MOTOR TEMPERATURE EXCEEDED ITS THERMAL LIMIT, REACHING 110°C. THIS TRIGGERED FAULT 1290 (FAULT_ANALOG_MOTOR_OVER_TEMP): ANALOG MOTOR TEMPERATURE OVER THE THERMAL LIMIT, HALTING COMPRESSION AND ILLUMINATING THE YELLOW ALERT TRIANGLE INDICATOR. THE NXT PLATFORM PASSED THE PRELIMINARY FUNCTIONAL TEST WITHOUT FAULTS OR ERRORS. THE PLATFORM WAS TESTED USING THE MZTF UNTIL THE BATTERY WAS COMPLETELY DISCHARGED, WITH NO FAULTS OR ERRORS DETECTED. THE FAN WAS CHECKED AND VERIFIED TO BE FUNCTIONING NORMALLY. THE AUTOPULSE PLATFORM FUNCTIONED APPROPRIATELY AND PERFORMED AS INTENDED. FOLLOWING THE SERVICE, THE AUTOPULSE NXT PLATFORM PASSED THE FINAL TESTS WITHOUT ISSUES.

    Description of Event or Problem · 0

    DURING THE RESUSCITATION ATTEMPT USING THE AUTOPULSE NXT PLATFORM (SN (B)(6)THE FIRST BATTERY DEPLETED AFTER PERFORMING COMPRESSIONS, AND IT WAS REPLACED WITH THE BACKUP BATTERY. THE NXT PLATFORM WAS RESTARTED AND PERFORMED COMPRESSIONS FOR APPROXIMATELY 17 MINUTES BEFORE EXPERIENCING WHAT APPEARED TO BE AN OVERHEATING EVENT. THE CREW SWITCHED BACK TO MANUAL CPR. NO PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    46101 AUTOPULSE NXT RESUSCITATION SYSTEM CARDIAC RESUSCITATOR, LINE-POWERED DRM ZOLL CIRCULATION, INC. MODEL 200 00849111003384

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown