BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE NXT RESUSCITATION SYSTEM

    MDR report key: 21980583 · Received May 7, 2025

    Report

    Report Number
    3010617000-2025-00332
    Event Type
    Malfunction
    Date Received
    May 7, 2025
    Date of Event
    April 12, 2025
    Report Date
    May 7, 2025
    Manufacturer
    ZOLL CIRCULATION, INC.
    Product Code
    DRM
    UDI-DI
    00849111003384
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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 PLATFORM FOR INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED IF AND WHEN THE PRODUCT IS RETURNED, AND THE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THE ALERT YELLOW TRIANGLE INDICATOR ILLUMINATES ON THE AUTOPULSE NXT PLATFORM (SN (B)(6)), AND ONLY ONE SIDE OF THE NXT BAND RETRACTS ON MULTIPLE POWER-UP ATTEMPTS. NO FURTHER INFORMATION WAS PROVIDED. IT IS UNKNOWN WHEN THE PROBLEM OCCURRED. HOWEVER, PATIENT USE INFORMATION WAS REQUESTED, BUT NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    138412 AUTOPULSE NXT RESUSCITATION SYSTEM CARDIAC RESUSCITATOR, LINE-POWERED DRM ZOLL CIRCULATION, INC. MODEL 200 00849111003384

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown