AutoPulse NXT Resuscitation System Model 200 (REF 8700-001010)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00849111003049), received between Feb 9, 2024 and Dec 4, 2025 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Use of Device Problem” (6 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 4, 2025Use of Device Problem; Use of Device Problem

  THE CUSTOMER REPORTED THAT THE CREW ATTEMPTED TO DEPLOY THE AUTOPULSE NXT PLATFORM (SN (B)(6) ON A PATIENT. THE CUSTOMER STATED THAT, TO THE BEST OF THEIR KNOWLEDGE, THE NXT BAND (LOT # UNKNOWN) WAS CORRECTLY ATTACHED TO THE NXT PLATFORM. UPON INITIAL INSPECTION, BOTH SIDES OF THE NXT BAND APPEARED TO BE IN GOOD WORKING CONDITION. THE NXT PLATFORM WAS USED ON A CONCRETE SURFACE, AND NO AUDIBLE ALERTS OR VISIBLE FAULTS WERE DISPLAYED ON THE CONTROL PANEL WHEN IT WAS POWERED ON. ACCORDING TO THE CUSTOMER, THE BAND INITIATED CORRECTLY; HOWEVER, SHORTLY THEREAFTER, THE BAND ON THE PATIENT'S RIGHT SIDE WENT SLACK. SIMULTANEOUSLY, THE LEFT-SIDE BAND SHIFTED AND BEGAN CONTRACTING IRREGULARLY, DELIVERING COMPRESSIONS SOLELY TO THE LEFT SIDE OF THE PATIENT'S CHEST. NO ONE ON SCENE NOTICED ANY WARNINGS OR LIGHTS ON THE PLATFORM'S CONTROL PANEL. THE USE OF THE NXT PLATFORM WAS DISCONTINUED, AND MANUAL CHEST COMPRESSIONS WERE INITIATED. THE CREW INSPECTED THE NXT PLATFORM AND ATTEMPTED TO REDEPLOY THE DEVICE, BUT THE SAME ISSUE OCCURRED. AFTER A THIRD UNSUCCESSFUL ATTEMPT, MANUAL COMPRESSIONS WERE CONTINUED FOR THE REMAINDER OF THE ENCOUNTER. NO CONSEQUENCES OR IMPACTS ON THE PATIENT. THE CREW

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23721399 ↗
• MalfunctionMay 16, 2024Use of Device Problem; Use of Device Problem

  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 LAST

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19337221 ↗
• MalfunctionMay 1, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem

  THE CUSTOMER REPORTED THAT THE AUTOPULSE NXT PLATFORM (SN (B)(6) DISPLAYED A FLASHING YELLOW TRIANGLE ALERT DURING A TRAINING SESSION. THE CUSTOMER PAUSED THE NXT PLATFORM AND COMPRESSIONS STOPPED. AFTER RESUMING THE NXT PLATFORM, THE YELLOW TRIANGLE ALERT FLASHED AGAIN. THE CUSTOMER STATED THEY PROBABLY TURNED OFF THE NXT PLATFORM THREE TIMES AND REMOVED THE NXT BATTERY, BUT THE ISSUE PERSISTED. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19226594 ↗
• MalfunctionMar 6, 2024Use of Device Problem; Use of Device Problem

  THE AUTOPULSE NXT PLATFORM (SN (B)(6)) AND FULLY CHARGED AUTOPULSE NXT LITHIUM-ION BATTERY (SN (B)(6)) WERE USED TO RESUSCITATE A 135 LBS. FEMALE PATIENT IN CARDIAC ARREST. THE CUSTOMER REPORTED THAT THE AUTOPULSE NXT PLATFORM PROVIDED LESS THAN 30 MINUTES OF COMPRESSIONS BEFORE IT DISPLAYED A FLASHING BATTERY LOW INDICATION (TRIANGLE CAUTION) AND ONE LIGHT ON THE BATTERY. THE PATIENT EVENT OCCURRED INDOORS, AND THE APPROXIMATE AMBIENT TEMPERATURE WAS 70 °F. NO CONSEQUENCES OR IMPACTS ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18853083 ↗
• MalfunctionMar 6, 2024Use of Device Problem; Use of Device Problem

  THE AUTOPULSE NXT PLATFORM (SN (B)(6)) AND FULLY CHARGED AUTOPULSE NXT LITHIUM-ION BATTERY (SN (B)(6)) WERE USED TO RESUSCITATE A 180 LBS. FEMALE PATIENT IN CARDIAC ARREST. THE CUSTOMER REPORTED THAT THE AUTOPULSE NXT PLATFORM PROVIDED LESS THAN 30 MINUTES OF COMPRESSIONS BEFORE IT DISPLAYED A FLASHING BATTERY LOW INDICATION (TRIANGLE CAUTION) AND ONE LIGHT ON THE BATTERY. THE PATIENT EVENT OCCURRED INDOORS, AND THE APPROXIMATE AMBIENT TEMPERATURE WAS 70 °F. NO CONSEQUENCES OR IMPACTS ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18853068 ↗
• MalfunctionFeb 13, 2024Use of Device Problem; Unexpected Shutdown; Use of Device Problem; Unexpected Shutdown

  THE AUTOPULSE NXT PLATFORM SN (B)(6) WAS USED TO RESUSCITATE A 56-YEAR-OLD MALE PATIENT (HEIGHT: 6.2 FT AND WEIGHT: 300 LBS.) IN CARDIAC ARREST. THE CODE WAS INITIALLY RUN OUTSIDE ON THE STREET ( APPROXIMATELY 20°F AMBIENT TEMPERATURE AT 10:30 PM, VERY COLD OUTSIDE). THE PATIENT'S JACKET WAS REMOVED, AND THE PATIENT'S SHIRT WAS CUT AND TUCKED UNDER HIS BACK. THE NXT PLATFORM WAS DEPLOYED, AND WHEN THE CREW ATTEMPTED TO START COMPRESSIONS, THE NXT PLATFORM STARTED SIZING THE PATIENT AND THEN RELEASED THE BAND BUT DID NOT START COMPRESSING. THE CREW CONTINUED WITH MANUAL CPR. WHEN THE CREW SUPERVISOR ARRIVED ON THE SCENE, THE SUPERVISOR CHECKED THE BAND AND DETECTED THAT THE NXT LIFEBAND PINS WERE NOT SECURED ON THE SPOOLS. THE SUPERVISOR CORRECTLY INSERTED THE NXT LIFEBAND PINS INTO THE NXT PLATFORM, INITIATING THE COMPRESSIONS. ABOUT 20 TO 25 MINUTES INTO THE CODE, THE CREW NOTICED THE "PLASTIC BURN SMELL." THE PATIENT WAS THEN MOVED FROM THE SCENE TO THE AMBULANCE USING A FERNO STRETCHER. THE NXT PLATFORM GENERATED A LOW BATTERY ALERT WHEN THE CREW TRANSPORTED THE PATIENT INTO THE AMBULANCE. THE CREW PROCEEDED TO REPLACE THE NXT BATTERY. THE FIRST NXT BATTERY WAS NOTICED TO BE WAR

  Patient problems: Insufficient Information

  MAUDE report 18699774 ↗
• MalfunctionFeb 9, 2024Use of Device Problem; Use of Device Problem

  THE AUTOPULSE NXT PLATFORM (SN (B)(6)) WAS USED TO RESUSCITATE A PATIENT IN CARDIAC ARREST. THE PATIENT'S CLOTHES WERE REMOVED, AND THE PATIENT WAS PLACED ON THE PLATFORM WITH BARE SKIN. THE AUTOPULSE NXT PLATFORM WAS USED ON A HARDWOOD FLOOR INSIDE THE PATIENT'S HOUSE LIVING ROOM (~ 60F DEGREES AMBIENT TEMPERATURE). THE CUSTOMER USED THE NXT CARRY CASE THROUGHOUT THE ENTIRE CALL. THE NXT CARRY CASE WAS FIRST USED ON A HARDWOOD FLOOR IN THE RESIDENCE, AND LATER, IT WAS MOVED TO THE COT WITH A SHEET ON THE MATTRESS. THE CREW REPORTED THAT NOTHING WAS BLOCKING THE NXT PLATFORM VENTS. THE NXT PLATFORM DELIVERED COMPRESSIONS WITH THE FIRST BATTERY FOR ABOUT 20 MINUTES, AND AT THAT POINT, THE CREW NOTICED A SMELL DESCRIBED AS "BURNED PLASTIC." THE CREW KEPT THE NXT PLATFORM RUNNING REGARDLESS OF THE SMELL UNTIL THE PLATFORM DISPLAYED A LOW BATTERY ALERT. THE CREW PROCEEDED TO SWITCH TO A SECOND BATTERY. A FEW MINUTES (4 TO 5 MINUTES) AFTER THE SECOND BATTERY WAS DEPLOYED, THE PATIENT CALL WAS TERMINATED. THE NXT PLATFORM DID NOT STOP COMPRESSIONS, BUT THE CREW STATED THAT THE "BURNED PLASTIC" SMELL WAS NOTICEABLE AS IT QUICKLY TRAVELED THROUGH THE ER ROOM. PER THE CUSTOMER, THE BATTERIE

  Patient problems: Insufficient Information

  MAUDE report 18682252 ↗