BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE NXT RESUSCITATION SYSTEM

    MDR report key: 23930617 · Received December 30, 2025

    Report

    Report Number
    3010617000-2025-00923
    Event Type
    Malfunction
    Date Received
    December 30, 2025
    Date of Event
    December 10, 2025
    Report Date
    January 23, 2026
    Manufacturer
    ZOLL CIRCULATION, INC
    Product Code
    DRM
    UDI-DI
    00849111003384
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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. ZOLL HAS RECEIVED THE AUTOPULSE NXT PLATFORM FOR INVESTIGATION. A SUPPLEMENTAL REPORT WILL BE FILED WHEN THE INVESTIGATION HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 0

    THE CUSTOMER REPORTED COMPLAINT THE AUTOPULSE NXT PLATFORM (SN (B)(6) STOPPED COMPRESSIONS WAS CONFIRMED DURING ARCHIVE REVIEW BUT NOT CONFIRMED DURING FUNCTIONAL TESTING. THE CUSTOMER REPORTED COMPLAINT COULD NOT BE REPRODUCED. THE AUTOPULSE PLATFORM FUNCTIONED APPROPRIATELY AND PERFORMED AS INTENDED. BASED ON THE ARCHIVE LOG REVIEW, THE CUSTOMER COMPLAINT WAS CONFIRMED. THE PLATFORM WAS USED FOR A TREATMENT SESSION THAT LASTED 19 MINUTES AND 38 SECONDS ON OCTOBER 13, DURING WHICH 1,586 COMPRESSIONS WERE DELIVERED. THERE HAS BEEN NO ACTIVITY FROM THE DEVICE SINCE OCTOBER 13. THIS DATE IS LIKELY WHEN THE PROBLEM OCCURRED. THE SESSION ENDED DUE TO LOW BATTERY VOLTAGE, INDICATED BY FAULT CODE 1160, AND THE BATTERY WAS SUBSEQUENTLY REMOVED. WITHIN 4 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 CODE 1290, STOPPING THE COMPRESSIONS AND CAUSING THE YELLOW ALERT TRIANGLE INDICATOR TO ILLUMINATE. THE USER POWERED OFF THE PLATFORM. AFTER BEING OFF FOR 27 MINUTES, THE PLATFORM POWERED ON FOR ANOTHER TREATMENT SESSION THAT LASTED 10 MINUTES DURING WHICH 887 COMPRESSIONS WERE DELIVERED. THE SESSION ENDED DUE TO FAULT CODE 1210, AND THE PLATFORM SHUT OFF ON ITS OWN. FAULT CODE 1210 INDICATES THE PLATFORM DETECTS THAT EITHER NO PATIENT IS PRESENT OR THE BAND IS OPEN. THE AUTOPULSE NXT PLATFORM PASSED THE PRELIMINARY FUNCTIONAL TEST WITHOUT FAULTS OR ERRORS. THE NXT BAND ATTACHED WITHOUT ANY ISSUE. THE PLATFORM WAS TESTED USING THE MZTF (MEDIUM ZOLL TEST FIXTURE) UNTIL THE BATTERY WAS COMPLETELY DISCHARGED, WITH NO FAULTS OR ERRORS DETECTED. THE AUTOPULSE NXT PLATFORM FUNCTIONED APPROPRIATELY AND PERFORMED AS INTENDED. THE REPORTED COMPLAINT WAS NOT REPRODUCED. FOLLOWING SERVICE, THE AUTOPULSE NXT PLATFORM PASSED THE RUN-IN TEST WITHOUT ANY FAULT OR ERROR. THE AUTOPULSE PASSED THE FINAL TESTING WITHOUT ANY FAULT OR ERROR.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THEY WERE DISPATCHED TO A CARDIAC ARREST. THE AUTOPULSE NXT PLATFORM (B)(6) WAS APPLIED TO THE APPROXIMATELY 52-YEAR-OLD, 250-270-POUND MALE PATIENT AFTER SEVERAL MINUTES. THE MED UNIT BEGAN TRANSPORT TO THE PCI FACILITY. AFTER APPROXIMATELY 20 MINUTES, THE PLATFORM SUDDENLY STOPPED ON ITS OWN. NO ONE WAS TOUCHING THE CONTROLS AT THE TIME. ACCORDING TO THE CUSTOMER, NO WARNING LIGHTS WERE NOTED. THE GREEN START BUTTON WAS PRESSED AND THE PLATFORM RESUMED AS NORMAL. AFTER APPROXIMATELY 3 MINS, A BATTERY CHANGE OCCURRED, AND THE PLATFORM RESUMED NORMAL OPERATIONS. THERE IS NO SUSPECTED BATTERY MALFUNCTION. AFTER 3-5 MINUTES, THE NXT BAND (LOT UNKNOWN) RIPPED OFF THE PATIENT. THE CREW CONTINUED WITH MANUAL CPR AND THE NXT BAND WAS ATTEMPTED TO BE REATTACHED UNSUCCESSFULLY. THE PATIENT WAS KEPT ON THE PLATFORM BUT THERE WERE NO FURTHER ATTEMPTS TO USE THE PLATFORM. MANUAL CPR WAS PERFORMED UNTIL HAND OFF AT THE HOSPITAL. NO CONSEQUENCES OR IMPACT ON THE PATIENT. AFTER THE CALL WAS COMPLETED, INSPECTION OF THE NXT BAND FOUND THAT THE VELCRO RIPPED PARTIALLY OFF. THE BAND RIPPED/TORE MID-WAY BETWEEN THE CONNECTION TO BOARD AND LARGEST PART OF THE BAND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1770172 AUTOPULSE NXT RESUSCITATION SYSTEM CARDIAC RESUSCITATOR, LINE-POWERED DRM ZOLL CIRCULATION, INC MODEL 200 00849111003384

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Male