BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE NXT RESUSCITATION SYSTEM

    MDR report key: 22385229 · Received July 2, 2025

    Report

    Report Number
    3010617000-2025-00441
    Event Type
    Malfunction
    Date Received
    July 2, 2025
    Date of Event
    June 11, 2025
    Report Date
    August 5, 2025
    Manufacturer
    ZOLL CIRCULATION, INC
    Product Code
    DRM
    UDI-DI
    00849111003384
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    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. THE AUTOPULSE NXT PLATFORM IN THE COMPLAINT HAS NOT BEEN RETURNED FOR INVESTIGATION. A SUPPLEMENTAL REPORT WILL BE FILED IF AND WHEN THE PRODUCT IS RETURNED AND INVESTIGATION HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 0

    THE CUSTOMER REPORTED COMPLAINT THAT THE YELLOW TRIANGLE INDICATOR ON THE AUTOPULSE NXT PLATFORM (SN (B)(6) FLASHES AND THE DEVICE DOES NOT START RESUSCITATION WAS CONFIRMED DURING ARCHIVE REVIEW AND FUNCTIONAL TESTING. THE ROOT CAUSE WAS THAT THE ENCODER CABLE HAD COME LOOSE, WHICH WAS CAUSING THE MOTOR TO STALL. THE LOCKING TAB ON THE ENCODER CABLE WAS WORN OUT, PREVENTING THE CABLE FROM LOCKING SECURELY IN PLACE. REVIEW OF THE ARCHIVE DATA INDICATED FAULT CODE 1072 (MOTOR STALLED WHILE RUNNING), THUS, CONFIRMING THE REPORTED COMPLAINT. THE AP NXT PLATFORM FAILED THE PRELIMINARY FUNCTIONAL TESTING BECAUSE THE RIGHT AND LEFT-SIDE BAND SLOTS ATTACHMENTS WERE NOT IN THE HOME POSITION, RELATED TO THE REPORTED COMPLAINT. UPON OPENING THE BOTTOM ENCLOSURE, IT WAS OBSERVED THAT THE ENCODER CABLE HAD COME LOOSE, WHICH CAUSED THE MOTOR TO STALL. WHEN THE MOTOR STALLED THE BAND SLOT ATTACHMENTS DID NOT STOP AT THE HOME POSITION. THE YELLOW TRIANGLE INDICATOR FLASHES, AND THE DEVICE DOES NOT START RESUSCITATION, THUS CONFIRMING THE REPORTED COMPLAINT. DURING THE ATTEMPT TO RECONNECT THE ENCODER CABLE, THE CABLE DID NOT SECURELY LOCK IN PLACE AND WAS EASY TO PULL OUT AGAIN. IT WAS OBSERVED THAT THE LOCKING TAB ON THE ENCODER CABLE WAS WORN OUT. AFTER REPLACING THE ENCODER CABLE, THE ISSUE WAS RESOLVED. THE BAND SLOT ATTACHMENTS OF THE PLATFORM WERE SET TO THE HOME POSITION, AND A FULL TRAVEL TEST WAS PERFORMED, VERIFYING THAT THE PLATFORM GOES THROUGH THE CYCLE TO FIND THE PATIENT'S HOME WITHOUT ERRORS. THE PLATFORM WAS TESTED USING MZTF (MEDIUM ZOLL TEST FIXTURE) WITH ONE BATTERY UNTIL IT WAS DISCHARGED, AND NO FAULTS OR ERRORS WERE FOUND. FOLLOWING SERVICE, THE AUTOPULSE NXT PLATFORM PASSED THE RUN-IN TEST WITHOUT ANY FAULT OR ERROR. THE AUTOPULSE PASSED THE FINAL TESTING WITHOUT ANY FAULT OR ERROR. HISTORICAL COMPLAINTS WERE REVIEWED FOR SERVICE INFORMATION RELATED TO THE REPORTED COMPLAINT, AND THERE WAS NO PREVIOUS HISTORY OF COMPLAINTS FOR AUTOPULSE NXT PLATFORM WITH SN (B)(6).

    Description of Event or Problem · 0

    WHEN THE NXT BAND AND THE AUTOPULSE NXT LI-ION BATTERY ARE INSERTED AND THE AUTOPULSE NXT PLATFORM (SN (B)(6) IS SWITCHED ON, EVERYTHING LOOKS OK. HOWEVER, AS SOON AS THE PLATFORM IS STARTED BY PRESSING THE GREEN BUTTON, THE YELLOW TRIANGLE INDICATOR FLASHES AND THE DEVICE DOES NOT START RESUSCITATION. 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
    8099 AUTOPULSE NXT RESUSCITATION SYSTEM CARDIAC RESUSCITATOR, LINE-POWERED DRM ZOLL CIRCULATION, INC MODEL 200 00849111003384

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown