BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE NXT RESUSCITATION SYSTEM

    MDR report key: 23812575 · Received December 15, 2025

    Report

    Report Number
    3010617000-2025-00857
    Event Type
    Malfunction
    Date Received
    December 15, 2025
    Date of Event
    November 20, 2025
    Report Date
    December 15, 2025
    Manufacturer
    ZOLL CIRCULATION, INC.
    Product Code
    DRM
    UDI-DI
    00849111003384
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    FOR G4: PMA/510(K): PREMARKET SUBMISSION NUMBER NOT AVAILABLE/NOT RELEASED. DURING SERVICING AT ZOLL ON (B)(6) 2025, THE AUTOPULSE NXT PLATFORM (SN (B)(6)) FAILED FUNCTIONAL TESTING DUE TO A FLASHING YELLOW WARNING LIGHT UPON POWERING THE DEVICE. THE INVESTIGATION DETERMINED THAT THE ROOT CAUSE WAS A FAILED COOLING FAN, RESULTING FROM SHORTED WIRING DUE TO THE INGRESS OF BLOOD OR A MIXTURE OF BLOOD AND OTHER FLUIDS. THE FAN WAS REPLACED TO REMEDY THE PROBLEM. FOLLOWING THE SERVICE, THE AUTOPULSE NXT PLATFORM PASSED THE RUN-IN TEST WITHOUT ANY FAULTS OR ERRORS. THE AUTOPULSE PASSED ITS FINAL TESTING WITHOUT ANY FAULTS OR ERRORS. HISTORICAL COMPLAINTS WERE REVIEWED FOR SERVICE INFORMATION RELATED TO THE REPORTED COMPLAINT, AND THERE WAS NO PREVIOUS HISTORY OF COMPLAINTS REPORTED FOR THE AUTOPULSE NXT PLATFORM WITH THE SN (B)(6).

    Description of Event or Problem · 0

    DURING SERVICING AT ZOLL ON (B)(6) 2025, THE AUTOPULSE NXT PLATFORM (SN (B)(6)) FAILED FUNCTIONAL TESTING, AS A FLASHING YELLOW WARNING LIGHT WAS DISPLAYED UPON POWERING THE DEVICE. NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1688113 AUTOPULSE NXT RESUSCITATION SYSTEM CARDIAC RESUSCITATOR, LINE-POWERED DRM ZOLL CIRCULATION, INC. MODEL 200 00849111003384

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown