BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AUTOPULSE NXT RESUSCITATION SYSTEM

    MDR report key: 21802656 · Received April 8, 2025

    Report

    Report Number
    3010617000-2025-00233
    Event Type
    Injury
    Date Received
    April 8, 2025
    Date of Event
    March 9, 2025
    Report Date
    July 24, 2025
    Manufacturer
    ZOLL CIRCULATION, INC.
    Product Code
    DRM
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE ASSOCIATED WITH THIS COMPLAINT HAS BEEN RECEIVED, HOWEVER, THE INVESTIGATION IS PENDING. A FOLLOW-UP REPORT WILL BE FILED WHEN THE INVESTIGATION HAS BEEN COMPLETED. THE EVENT OF SKIN INJURIES WAS SERIOUS DUE TO THE LOCATION AND THE TIME POINT. THE EVENT OF SKIN INJURIES WAS CAUSALLY RELATED TO THE AUTOPULSE DEVICE AND A PROCEDURE. THE DEATH WAS NOT RELATED TO THE AUTOPULSE DEVICE. THE AUTOPULSE IS USED AS AN ADJUNCT TO MANUAL CPR, ADJUNCTIVE USE ONLY INDICATION IS PROMINENTLY DISPLAYED ON DEVICE LABELS AND IN THE DEVICE MANUAL. THE BENEFIT OF USING THE AUTOPULSE IS THAT IT IN PART SUBSTITUTES MECHANICAL COMPRESSIONS FOR THE PHYSICAL LABOR OF MANUAL CHEST COMPRESSIONS WHEN EFFECTIVE MANUAL CPR IS NOT POSSIBLE. IF THE AUTOPULSE DID NOT START OR UNEXPECTEDLY STOPS COMPRESSIONS, RESCUER SHOULD REVERT TO MANUAL CPR, WHICH IS THE STANDARD OF CARE. THE AUTOPULSE IS INTENDED TO BE USED AS AN ADJUNCT TO MANUAL CPR ON ADULT PATIENTS. IN CASE OF STOPPAGE OF AUTOPULSE THE TRAINED USER REVERTS TO MANUAL CPR. THE TRANSITION FROM AUTOPULSE TO MANUAL CPR BY TRAINED USERS IS SIMILAR TO THE TIME NECESSARY FOR RESCUER ROTATION AND PRESENTS THE SAME WORKFLOW AS MANUAL CPR. HENCE, BASED ON AVAILABLE INFORMATION, THE PATIENTS' OUTCOME WAS NOT NEGATIVELY IMPACTED BY THE INTERRUPTIONS WHEN COMPARED TO STANDARD OF CARE MANUAL CPR. ACCORDING TO MULTIPLE STUDIES, OUT-OF-HOSPITAL CARDIAC ARREST (OHCA) IS CONSIDERED ONE OF THE LEADING CAUSES OF DEATH IN INDUSTRIALIZED NATIONS, WITH A SIGNIFICANT NUMBER OF DEATHS OCCURRING OUTSIDE OF A HOSPITAL SETTING, MAKING IT A MAJOR PUBLIC HEALTH CONCERN; THIS INFORMATION IS SUPPORTED BY RESEARCH FROM THE CDC, STUDIES ON GLOBAL MORTALITY RATES, AND DATA FROM VARIOUS CARDIAC ARREST REGISTRIES. SURVIVAL TO HOSPITAL DISCHARGE AFTER NON-TRAUMATIC EMERGENCY MEDICAL SERVICES-TREATED CARDIAC ARREST WITH ANY FIRST RECORDED RHYTHM WAS AROUND 10% FOR PATIENTS OF ANY AGE (MOZAFFARIAN, CIRCULATION, 2016; EBIOMEDICINE 2023). DEATH IS AN EXPECTED OUTCOME FOR OHCA. FOR G4: PMA/510(K): PREMARKET SUBMISSION NUMBER NOT AVAILABLE/NOT RELEASED.

    Additional Manufacturer Narrative · 0

    THE REPORTED COMPLAINT THAT THE AUTOPULSE NXT PLATFORM (SN (B)(6)) FAILED TO PROVIDE EFFECTIVE CHEST COMPRESSIONS WAS CONFIRMED DURING THE ARCHIVE DATA REVIEW BUT NOT DURING THE FUNCTIONAL TESTING. BASED ON THE ARCHIVE DATA REVIEW, THE PATIENT SIZE FLUCTUATES UNEXPECTEDLY ON MULTIPLE OCCASIONS, PARTICULARLY EACH TIME THE PAUSE FUNCTION IS ACCESSED. THIS BEHAVIOR SUGGESTS POSSIBLE USER INTERFERENCE WITH THE NXT BAND, ESPECIALLY FOLLOWING THE SELECTION OF THE START BUTTON, WHICH MAY LEAD TO INSUFFICIENT COMPRESSION. THE CUSTOMER REPORTED AN ISSUE THAT THE AUTOPULSE NXT PLATFORM EMITTED AN ODOR WAS NOT CONFIRMED DURING THE FUNCTIONAL TESTING. VISUAL INSPECTION OF THE RETURNED AUTOPULSE NXT PLATFORM SHOWED NO PHYSICAL DAMAGE. THE ARCHIVE DATA INDICATED FAULT 1290 (FAULT_ANALOG_MOTOR_OVER_TEMP): ANALOG MOTOR TEMPERATURE OVER THE THERMAL LIMIT, AS THE INTERNAL MOTOR TEMPERATURE REACHED 99°C, LIKELY RELATED TO THE REPORTED COMPLAINT OF THE ODOR AND AN INCREASE IN COOLING FAN SPEED OF THE PLATFORM. THE AUTOPULSE NXT PLATFORM PASSED PRELIMINARY FUNCTIONAL TESTING WITHOUT ANY FAULT OR ERROR. THE BURNING SMELL WAS NOT CONFIRMED DURING THE FUNCTIONAL TESTING OF THE NXT PLATFORM. A THOROUGH INSPECTION OF THE PLATFORM FOUND NO SIGNS INDICATIVE OF A SHORT CIRCUIT, THERMAL DAMAGE, OR ELECTRICAL FIRE. THE PLATFORM UNDERWENT CONTINUOUS TESTING USING THE MEDIUM ZOLL TEST FIXTURE (MZTF) WITH MULTIPLE BATTERIES UNTIL THEY WERE DISCHARGED WITHOUT ANY FAULTS OR ERRORS. FOLLOWING THE SERVICE, THE NXT PLATFORM WAS TESTED WITH KNOWN-GOOD NXT BATTERIES UNTIL FULLY DISCHARGED WITHOUT ANY FAULTS OR ERRORS. THE AUTOPULSE NXT PLATFORM PASSED THE FINAL TESTING WITHOUT ANY ISSUES.

    Additional Manufacturer Narrative · 0

    CORRECTION: H1, TYPE OF REPORTABLE EVENT.

    Description of Event or Problem · 0

    THE AUTOPULSE NXT PLATFORM (B)(6) FAILED TO PROVIDE EFFECTIVE CHEST COMPRESSIONS DURING THE CALL FOR THE 66-YEAR-OLD PATIENT (285 LB WEIGHT AND 72" HEIGHT). THE PATIENT HAD A PAST MEDICAL HISTORY OF ATRIAL FIBRILLATION (AFIB). WHILE THE PATIENT WAS CARRIED BY SIX PEOPLE ON THE CASE TARP WHEN THE NXT PLATFORM PERFORMED COMPRESSIONS, THE AUTOPULSE NXT BAND (LOT# 200697) SHIFTED AND HAD TO BE ADJUSTED. THE PLATFORM PERFORMED COMPRESSIONS FOR AN UNKNOWN TIME DURING THE TRANSPORT BEFORE THE DEVICE HAD TO BE TURNED OFF AT THE HOSPITAL DUE TO THE STRONG ODOR, AN INCREASE IN COOLING FAN SPEED, AND A PROGRESSIVELY STRONGER BURNING SMELL, FOLLOWED BY AN INTENSELY LOUD FAN OPERATION. THE INITIAL PATIENT'S ETCO2 WAS IN THE 40S DROPPING TO THE 20S AFTER THE PLATFORM DEPLOYMENT. MANUAL CPR WAS RESUMED FOR AN UNKNOWN TIME, RAISING THE PATIENT'S ETCO2 TO 60-70S. AFTER THE PATIENT WAS PRONOUNCED DEAD, SKIN DAMAGE WAS OBSERVED BILATERALLY UNDER THE ARMPITS IN THE MIDAXILLARY REGION, COINCIDING WITH AREAS OF CONTACT WITH THE NXT BAND. THE INJURIES INCLUDED AN ABRASION ON THE LEFT SIDE AND AN ERODED CHANNEL OR PARTIAL-THICKNESS BURN ON THE RIGHT. NO TREATMENT WAS PROVIDED, AS THE INJURIES WERE IDENTIFIED POST-MORTEM. THE CUSTOMER DID NOT PROVIDE INFORMATION REGARDING THE RELATIONSHIP BETWEEN THE DEATH AND THE ALLEGED MALFUNCTION. HOWEVER, THE MEDICAL SAFETY ASSESSMENT (MSA) EVALUATED THE INCIDENT, AND IT WAS DETERMINED THAT THE DEATH WAS NOT RELATED TO THE AUTOPULSE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    517878 AUTOPULSE NXT RESUSCITATION SYSTEM CARDIAC RESUSCITATOR, LINE-POWERED DRM ZOLL CIRCULATION, INC. MODEL 200

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Unknown