BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE NXT RESUSCITATION SYSTEM

    MDR report key: 23271428 · Received October 10, 2025

    Report

    Report Number
    3010617000-2025-00709
    Event Type
    Malfunction
    Date Received
    October 10, 2025
    Date of Event
    September 17, 2025
    Report Date
    October 10, 2025
    Manufacturer
    ZOLL CIRCULATION, INC.
    Product Code
    DRM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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. NO SAFETY ISSUES WERE REPORTED. THE CUSTOMER COMPLAINT OF A BURNING SMELL FROM THE AUTOPULSE NXT PLATFORM (SN (B)(6) WAS VERIFIED DURING FUNCTIONAL TESTING. HOWEVER, THE SMELL DOES NOT AFFECT THE PLATFORM'S FUNCTIONALITY. THE BURNING SMELL EMITTED BY THE MOTOR IS EXPECTED, AS THIS PLATFORM DID NOT HAVE A "PRE-BAKED MOTOR". THE BURNING SMELL IS PRIMARILY DUE TO OIL RESIDUE BURNING OFF FROM THE MOTOR AS IT HEATS UP. THE BURNT SMELL SEEMED TO DISSIPATE AFTER CONTINUOUS TESTING USING THE MZTF WITH TWO BATTERIES. THE COMPLAINT THAT THE AUTOPULSE NXT PLATFORM BECAME VERY WARM WAS NOT CONFIRMED DURING THE FUNCTIONAL TESTING. CHECK THE TOP ENCLOSURE WHERE THE PATIENT IS POSITIONED; IT FEELS ONLY SLIGHTLY WARM TO THE TOUCH. THE FAN WAS OPERATING AT NORMAL SPEED. ADDITIONALLY, THE ARCHIVE DATA INDICATED THAT THE MOTOR TEMPERATURE REACHED 110°C, TRIGGERING FAULT 1290 (FAULT_ANALOG_MOTOR_OVER_TEMP) AND HALTING COMPRESSIONS. THIS OCCURRED BECAUSE THE DEVICE REQUIRED MORE ENERGY TO COMPRESS A LARGE/STIFF PATIENT LOAD, CAUSING THE MOTOR TO GENERATE MORE HEAT AND RAISING ITS TEMPERATURE ABOVE THE THERMAL LIMIT OF 110°C. THE ARCHIVE DATA INDICATED FAULT 1290 (FAULT_ANALOG_MOTOR_OVER_TEMP): ANALOG MOTOR TEMPERATURE OVER THE THERMAL LIMIT, RELATED TO THE REPORTED COMPLAINT. THE NXT PLATFORM PASSED THE FUNCTIONAL TEST WITHOUT FAULTS OR ERRORS. THE AUTOPULSE PLATFORM FUNCTIONED APPROPRIATELY AND PERFORMED AS INTENDED. FOLLOWING SERVICE, THE AUTOPULSE NXT PLATFORM PASSED THE FINAL TESTS WITHOUT ISSUES.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THE AUTOPULSE NXT PLATFORM SN (B)(6) EMITS A BURNING ODOR DURING A RESUSCITATION ATTEMPT. THE CUSTOMER REPORTED THAT THE NXT PLATFORM DISPLAYED AN ERROR, BUT THE CREW WAS UNABLE TO PROVIDE ANY ADDITIONAL INFORMATION. THE NXT PLATFORM HAD BEEN PERFORMING CHEST COMPRESSIONS FOR APPROXIMATELY 30 MINUTES WHEN THE BURNING SMELL BEGAN. THE CREW ALSO REPORTED THAT THE PLATFORM BECAME VERY WARM, AND THE ODOR WAS INTENSE WHEN THEY DECIDED TO SWITCH TO MANUAL COMPRESSIONS. NO CONSEQUENCES OR IMPACTS ON THE PATIENT. NO SAFETY ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2487680 AUTOPULSE NXT RESUSCITATION SYSTEM CARDIAC RESUSCITATOR, LINE-POWERED DRM ZOLL CIRCULATION, INC. MODEL 200

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown