BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE NXT PLATFORM

    MDR report key: 19337221 · Received May 16, 2024

    Report

    Report Number
    3010617000-2024-00396
    Event Type
    Malfunction
    Date Received
    May 16, 2024
    Date of Event
    April 21, 2024
    Report Date
    May 16, 2024
    Manufacturer
    ZOLL CIRCULATION
    Product Code
    DRM
    UDI-DI
    00849111003049
    PMA / PMN Number
    K221700
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZOLL HAS NOT RECEIVED THE AUTOPULSE NXT PLATFORM (SN (B)(6)) FOR INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED IF AND WHEN THE PRODUCT IS RETURNED, AND THE INVESTIGATION HAS BEEN COMPLETED. THE DEATH WAS NOT RELATED TO THE AUTOPULSE DEVICE. THE AUTOPULSE IS USED AS AN ADJUNCT TO MANUAL CPR; THE ADJUNCTIVE USE-ONLY INDICATION IS PROMINENTLY DISPLAYED ON DEVICE LABELS AND IN THE MANUAL. THE BENEFIT OF USING 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, THE 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 PATIENT'S OUTCOME WAS NOT NEGATIVELY IMPACTED BY INTERRUPTIONS COMPARED TO STANDARD OF CARE MANUAL CPR. OUT-OF-HOSPITAL CARDIAC ARREST (OHCA) IS ONE OF THE MAIN CAUSES OF DEATH IN INDUSTRIAL NATIONS. ABOUT 25% OF PATIENTS SURVIVE THIS EVENT AND MAKE IT TO THE HOSPITAL; EVEN FEWER PATIENTS SURVIVE AFTER 24 HOURS (NICHOL, NEJM, 2015). 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.

    Description of Event or Problem · 0

    A 65-70-YEAR-OLD MALE PATIENT (WEIGH ABOUT 160-180 LBS.) HAD CARDIAC ARREST AT HIS RESIDENCE AND WAS FOUND UNCONSCIOUS BY HIS FAMILY MEMBER. AFTER 4 MINUTES, THE RESPONDING AGENCY PERFORMED MANUAL CPR FOR 2 MINUTES BEFORE USING AUTOPULSE. THE CREW THEN DEPLOYED THE AUTOPULSE NXT PLATFORM (SN (B)(6)) TO RESUSCITATE THE PATIENT. DURING THE RESUSCITATION, THE FIRST NXT BATTERY LASTED FOR ABOUT 15 MINUTES. THE CREW WENT TO THE TRUCK AND GOT THE SECOND NXT BATTERY, WHICH SHOWED A FULL CHARGE UPON CHECKING THE CHARGE STATUS. THE RESUSCITATION WAS RESUMED USING THE SECOND NXT BATTERY, AND IT LASTED FOR LESS THAN 1 MINUTE. THE CREW IMMEDIATELY REVERTED TO MANUAL CPR. MANUAL CPR WAS PERFORMED FOR ABOUT 28 MINUTES. HOWEVER, THE PATIENT EXPIRED DURING THE RESUSCITATION ATTEMPT. THE PATIENT HAD A HISTORY OF DIABETES AND RENAL FAILURE AND WAS UNDER MEDICATIONS. IT IS UNKNOWN WHETHER THESE UNDERLYING CONDITIONS CONTRIBUTED TO OR CAUSED THE CARDIAC ARREST. THE PATIENT WAS PRONOUNCED DEAD AT THE HOSPITAL, AND PER THE CUSTOMER, THE PATIENT'S DEATH WAS NOT RELATED TO AUTOPULSE. THE SERIAL NUMBERS OF THE NXT BATTERIES USED DURING THE EVENT WERE (B)(6), BUT THE CUSTOMER DID NOT KNOW WHICH BATTERY LASTED 15 MINUTES OR LESS THAN 1 MINUTE. PER THE CUSTOMER, THE BATTERIES WERE FULLY CHARGED THE NIGHT BEFORE THE PATIENT EVENT, AND 4 GREEN LEDS WERE ILLUMINATED UPON STATUS CHECK. UPON RETURNING TO THE STATION, THE CREW PLACED THE BATTERIES IN THE NXT CHARGER (SN (B)(6)), AND THREE RED LIGHTS WERE ILLUMINATED ON THE BATTERY CHARGER PANEL. THE CUSTOMER THEN UNPLUGGED THE CHARGER AND PLUGGED IT BACK IN, AND THE CHARGER DISPLAYED GREEN LIGHTS. THE BATTERIES WERE THEN CHARGED SUCCESSFULLY. ZOLL REPRESENTATIVE VISITED THE CUSTOMER SITE AND TESTED BOTH BATTERIES USING THE SAME PLATFORM WITH HALF MANNEQUIN. EACH BATTERY RAN FOR OVER 20 MINUTES WITHOUT ISSUES AND SHOWED TWO GREEN BARS LEFT ON THE BATTERY STATUS INDICATOR. THE FAILURE COULD NOT BE DUPLICATED. THE CUSTOMER ALSO MENTIONED THAT THE SAME PLATFORM AND BATTERIES WERE USED ON ANOTHER CALL, AND BOTH DEVICES WORKED WITH NO ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    668274 AUTOPULSE NXT PLATFORM CARDIAC CHEST COMPRESSOR DRM ZOLL CIRCULATION NXT PLATFORM 00849111003049

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male