BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE LI-ION BATTERY

    MDR report key: 23206528 · Received October 2, 2025

    Report

    Report Number
    3010617000-2025-00712
    Event Type
    Malfunction
    Date Received
    October 2, 2025
    Date of Event
    August 30, 2025
    Report Date
    October 2, 2025
    Manufacturer
    ZOLL CIRCULATION, INC.
    Product Code
    DRM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, 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 BATTERY IN COMPLAINT FOR INVESTIGATION. A FOLLOW-UP REPORT WILL BE FILED IF AND WHEN THE PRODUCT IS RETURNED AND INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 0

    DURING A PATIENT CALL, THE AUTOPULSE NXT PLATFORM (SN (B)(6)) FAILED TO MAINTAIN OPERATION FOR THE EXPECTED DURATION WHEN USED WITH TWO SEPARATE AUTOPULSE NXT BATTERIES (SN (B)(6) AND (B)(6). ACCORDING TO THE REPORTER, EACH FULLY CHARGED BATTERY POWERED THE DEVICE FOR ONLY 10 MINUTES AND 15 MINUTES, RESPECTIVELY. THE PATIENT'S STATUS INFORMATION WAS REQUESTED, BUT THE CUSTOMER DID NOT PROVIDE A RESPONSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    276811 AUTOPULSE LI-ION BATTERY CARDIAC RESUSCITATOR, LINE-POWERED DRM ZOLL CIRCULATION, INC. MODEL 200

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown