BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE NXT RESUSCITATION SYSTEM

    MDR report key: 23930688 · Received December 30, 2025

    Report

    Report Number
    3010617000-2025-00945
    Event Type
    Malfunction
    Date Received
    December 30, 2025
    Date of Event
    December 10, 2025
    Report Date
    December 30, 2025
    Manufacturer
    ZOLL CIRCULATION, INC
    Product Code
    DRM
    UDI-DI
    00849111003025
    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 NOT RECEIVED THE AUTOPULSE NXT BAND IN THE COMPLAINT FOR INVESTIGATION. A SUPPLEMENTAL REPORT WILL BE FILED IF AND WHEN THE PRODUCT IS RETURNED AND INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THEY WERE DISPATCHED TO A CARDIAC ARREST. THE AUTOPULSE NXT PLATFORM (SN (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
    1710823 AUTOPULSE NXT RESUSCITATION SYSTEM CARDIAC RESUSCITATOR, LINE-POWERED DRM ZOLL CIRCULATION, INC MODEL 200 UNKNOWN 00849111003025

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Male