BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE NXT RESUSCITATION SYSTEM

    MDR report key: 21231517 · Received January 24, 2025

    Report

    Report Number
    3010617000-2025-00046
    Event Type
    Malfunction
    Date Received
    January 24, 2025
    Date of Event
    December 31, 2024
    Report Date
    January 24, 2025
    Manufacturer
    ZOLL CIRCULATION, INC.
    Product Code
    DRM
    UDI-DI
    00849111003384
    PMA / PMN Number
    K221700
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER'S COMPLAINT THAT THE AUTOPULSE NXT PLATFORM (SN (B)(6) DISPLAYED A YELLOW ALERT TRIANGLE INDICATOR LIGHT UPON POWERING ON WAS CONFIRMED DURING THE FUNCTIONAL TESTING, AND THE ARCHIVE DATA INDICATED FAULT 1300 (FAN FAULT), AS MENTIONED BY THE CUSTOMER. THE ROOT CAUSE OF THE FAULT WAS NOT CONCLUSIVELY DETERMINED. NEVERTHELESS, THE FAN ASSEMBLY WAS REPLACED AS A PREVENTIVE PRECAUTIONARY MEASURE, AS THE FAN MAY HAVE HAD SOME INTERMITTENT TECHNICAL PROBLEMS THAT COULD NOT BE DIRECTLY IDENTIFIED DURING THE FUNCTIONAL TESTING. THE ARCHIVE DATA INDICATED FAULT 1300 (FAULT_NO_FANS_FUN), CONFIRMING THE REPORTED COMPLAINT. THE AUTOPULSE NXT PLATFORM FAILED FUNCTIONAL TESTING DUE TO A FLASHING ALERT TRIANGLE INDICATOR LIGHT UPON POWERING UP, CONFIRMING THE REPORTED COMPLAINT. VERIFIED THAT THE FAN WAS ON AND AIRFLOW COULD BE FELT FROM THE RIGHT-SIDE PLATFORM BAFFLE. REMOVED THE BOTTOM COVER TO INSPECT THE FAN AND FOUND NO SIGNS OF DAMAGE. THE FAN CABLE WAS FULLY CONNECTED TO THE MAINBOARD. THE REMOVED COVERS WERE PLACED AND SECURED, THEN POWERED ON THE PLATFORM. THE PLATFORM DISPLAYED NO FAULT ALERTS. THE PLATFORM WAS TESTED USING THE MZTF (MEDIUM ZOLL TEST FIXTURE) WITH FOUR BATTERIES UNTIL FULLY DISCHARGED WITHOUT ANY FAULTS OR ERRORS. THE FAN ASSEMBLY WAS REPLACED AS A PREVENTIVE PRECAUTIONARY MEASURE, AS THE FAN MAY HAVE HAD SOME INTERMITTENT TECHNICAL PROBLEMS THAT COULD NOT BE DIRECTLY IDENTIFIED DURING THE FUNCTIONAL TESTING. FOLLOWING SERVICE, THE AUTOPULSE NXT PLATFORM PASSED THE RUN-IN AND FINAL TESTS WITHOUT FAULT OR ERROR. 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 SN (B)(6).

    Description of Event or Problem · 0

    THE AUTOPULSE NXT PLATFORM (SN (B)(6) DISPLAYED A YELLOW ALERT TRIANGLE INDICATOR LIGHT UPON POWERING ON DURING SHIFT CHECK. THE PERFORMANCE REPORT FROM THE NXT PLATFORM INDICATED FAULT 1300 (FAN FAULT). NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1056472 AUTOPULSE NXT RESUSCITATION SYSTEM CARDIAC RESUSCITATOR, LINE-POWERED DRM ZOLL CIRCULATION, INC. MODEL 200 00849111003384

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown