AutoPulse NXT Resuscitation System Model 200 (REF 8700-001070)Recalls & reported problems

Summary

The FDA's MAUDE database contains 130 adverse event reports that list this exact device (DI 00849111003384), received between Jun 21, 2024 and Sep 30, 2026 — classified as 2 injuries, 128 malfunctions.

The most frequently reported specific device problem is “Use of Device Problem” (85 reports).

1 FDA recall record name this device's identifier, 1 still open.

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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Mar 4, 2025Class IOpen, Classified

   AutoPulse NXT Resuscitation System may not provide adequate chest compressions or may stop compressions due to code FC1060.

   Z-1533-2025 · Root cause: Process change control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 130 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Use of Device Problem

  The customer reported that during a patient call, the AutoPulse NXT Platform (SN (b)(6) stopped delivering compressions. The customer stated that it is unknown whether the NXT Platform displayed any alert when it stopped delivering compressions. The customer mentioned that the NXT Platform ventilation openings were not blocked by clothing or the patient, but there was a hygiene barrier on the platform. The customer suspected that the platform's hygiene barrier may not have allowed sufficient airflow to the fan and that the batteries may have become hot. The customer didn't report any complaint related to the batteries used during the reported event and stated that the batteries have been functioning properly since then. The customer did not report any harm, injury, or death and stated that there was minimal impact on the patient, as they just resumed manual CPR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50941677 ↗
• MalfunctionSep 29, 2026Use of Device Problem; Visual Prompts will not Clear

  The AutoPulse NXT Platform (SN (b)(6)) was deployed for resuscitation. During resuscitation, the NXT Platform performed compressions for 15 minutes, then illuminated an alert yellow triangle LED. Manual CPR was performed for the rest of the call. No consequences or impacts on the patient. After the call, the customer replaced the NXT Battery used during the event with another Battery and tested the NXT Platform with a manikin. The NXT Platform stopped after performing 3 compressions and started emitting smoke. The customer removed the Battery and took the NXT Platform out of service.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50935010 ↗
• MalfunctionSep 29, 2026Use of Device Problem

  The customer reported that the patient had poor hemodynamics after using the AutoPulse NXT Platform (SN (b)(6) for resuscitation. The patient's IBP dropped drastically 2 minutes after switching to manual CPR. No additional information was provided. The patient's status information was requested, but the customer did not provide a response.

  Patient problems: Insufficient Information

  MAUDE report 50927139 ↗
• MalfunctionSep 26, 2026Device Emits Odor; Retraction Problem; Noise, Audible

  Patient problems: Insufficient Information

  MAUDE report 50906383 ↗
• MalfunctionSep 25, 2026Use of Device Problem; Visual Prompts will not Clear

  The customer reported that the AutoPulse NXT Platform (SN (b)(6)) stopped delivering compressions about 15-20 minutes into patient care and displayed the alert yellow triangle indicator. The crew did not troubleshoot the issue after the platform stopped compressions. They transitioned to manual CPR for the remainder of the call. The patient's status information was requested, but the customer did not provide a response.

  Patient problems: Insufficient Information

  MAUDE report 50893052 ↗
• MalfunctionSep 25, 2026Connection Problem

  The customer reported the AutoPulse NXT Platform (SN (b)(6) has band clip retention issues. The clips on the NXT Band do not fasten securely to the platform and disengage when tension is applied. Multiple bands were testing with the same result. This was noticed during shift check. No patient involvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50892784 ↗
• MalfunctionSep 25, 2026Noise, Audible

  The customer reported a very loud fan noise from the AutoPulse NXT Platform (SN (b)(6) after approximately 2 minutes of compressions during a simulation using the manikin. They thought it sounded like it was going to overheat. Per the customer, it reminded him of when a piece of electrical equipment gets hot and its internal fan kicks on, except much louder. They stopped and powered off the platform. The compressions performed seemed normal. No patient involvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50892705 ↗
• MalfunctionSep 24, 2026Retraction Problem; Noise, Audible

  Patient problems: Insufficient Information

  MAUDE report 50892279 ↗
• MalfunctionSep 21, 2026Visual Prompts will not Clear

  The customer reported that the AutoPulse NXT Platform (SN 01808) showed an alert yellow triangle LED during the resuscitation attempt. The performance report showed Alert 120 (Analog Motor Temperature Alert) and fault code 1290 (Analog Motor Temperature over the Thermal Limit). No delay in care was caused; the crew switched to manual CPR when the AutoPulse NXT Platform stopped working and continued the transport. No consequences or impacts on the patient.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50841082 ↗
• MalfunctionSep 20, 2026Use of Device Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50833659 ↗
• MalfunctionSep 16, 2026Use of Device Problem; Connection Problem

  The customer reported that the crew could not deploy the AutoPulse NXT Platform (SN (b)(6)) to resuscitate an 84-year-old male patient because the pin got jammed. No additional information was provided. The patient was pronounced dead at the scene.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50789262 ↗
• MalfunctionAug 19, 2026Device Emits Odor; Noise, Audible

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50332875 ↗
• MalfunctionAug 13, 2026Use of Device Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50240518 ↗
• MalfunctionMar 30, 2026Device Emits Odor; Unexpected Shutdown

  AFTER 15 MINUTES OF PROVIDING COMPRESSIONS DURING PATIENT USE, THE AUTOPULSE NXT PLATFORM (SN (B)(6) EMITTED AN ODOR CONSISTENT WITH OVERHEATING ELECTRONIC CIRCUIT COMPONENTS. THE CUSTOMER STATED THAT THE CREW WAS CONCERNED BECAUSE THEY THOUGHT THAT THE SMELL WAS FROM A BATTERY, AND THEY WERE IN A CLOSED AMBULANCE CAB TRANSPORTING A PATIENT TO THE EMERGENCY ROOM. THE CUSTOMER STATED THAT NO ALERT LIGHT ILLUMINATED, AND THE PLATFORM SHUT OFF WHEN THE CREW SMELLED THE ODOR. THE PATIENT WAS IN CARDIAC ARREST BOTH BEFORE AND AFTER THE AUTOPULSE WAS APPLIED. AFTER THE PLATFORM SHUT OFF, THE CREW DISCONTINUED USING THE NXT PLATFORM AND PERFORMED MANUAL CPR. NO CONSEQUENCES OR IMPACTS ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24709167 ↗
• MalfunctionMar 24, 2026Visual Prompts will not Clear

  THE CUSTOMER REPORTED THAT THE AUTOPULSE NXT PLATFORM (SN (B)(6)) FAILED TO DELIVER COMPRESSIONS PROPERLY DURING A RECENT CARDIAC ARREST. THE DEVICE INITIALLY DELIVERED THREE COMPRESSIONS, THEN STOPPED, DISPLAYING THE ALERT YELLOW TRIANGLE INDICATOR. THE CUSTOMER REPLACED THE NXT BAND WITH A NEW ONE; HOWEVER, THE DEVICE CONTINUED TO FAIL TO DELIVER COMPRESSIONS. THE CREW SWITCHED TO MANUAL CPR. NO CONSEQUENCES OR IMPACT TO THE PATIENT. THE NXT PLATFORM WAS CHECKED LATER; WHEN POWERED ON, IT DISPLAYS AN ALERT YELLOW TRIANGLE INDICATOR FLASHING AND DOES NOT INITIATE COMPRESSIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24679261 ↗
• MalfunctionMar 17, 2026Device Emits Odor; Use of Device Problem; Visual Prompts will not Clear

  THE CUSTOMER REPORTED WHILE USING A FULL-BODY MANIKIN AT THE CUSTOMER SITE FOR CREW TRAINING, THE AUTOPULSE NXT PLATFORM (B)(6) WOULD NOT CINCH DOWN EVEN WITH THE BANDS IN PLACE. THE CUSTOMER ALSO REPORTED THAT THE NXT PLATFORM EMITTED AN ODOR AND ILLUMINATED THE ALERT YELLOW TRIANGLE INDICATOR. THE ODOR SMELLED LIKE SOMETHING WAS BURNING. HOWEVER, THERE WASN'T ANY SAFETY CONCERN RELATED TO THE ODOR. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24622871 ↗
• MalfunctionMar 14, 2026Use of Device Problem

  THE EVENT INVOLVED A (B)(6) YEAR-OLD MALE (APPROX. 165 LBS) AT A PRIVATE RESIDENCE. THE CARDIAC ARREST WAS PRESUMED TO BE CARDIAC IN ORIGIN WITH NO OBSERVED SIGNS OF TRAUMA. THE ARREST WAS UNWITNESSED, WITH THE PATIENT LAST KNOWN CONSCIOUS APPROXIMATELY 30 MINUTES BEFORE DISCOVERY. NO BYSTANDER CPR WAS PERFORMED. UPON ARRIVAL, ANOTHER RESPONDING AGENCY PERFORMED MANUAL CPR FOR APPROXIMATELY 6 MINUTES BEFORE ATTEMPTING TO DEPLOY THE AUTOPULSE NXT PLATFORM. DURING DEPLOYMENT, THE PLATFORM (SN (B)(6) TOOK UP SLACK IN THE NXT BAND (LOT # 211084) BUT THEN STOPPED AND FAILED TO INITIATE COMPRESSIONS. FOLLOWING THE DEVICE FAILURE, THE CREW IMMEDIATELY TRANSITIONED BACK TO MANUAL CPR FOR APPROXIMATELY 12 MINUTES. ROSC WAS NOT ACHIEVED. THE PATIENT WAS PRONOUNCED DECEASED IN THE KITCHEN OF THE RESIDENCE BY AN EMERGENCY DEPARTMENT PHYSICIAN VIA TELEPHONE; THE CAUSE OF DEATH REMAINS UNKNOWN. NO DETRIMENTAL EFFECTS ATTRIBUTABLE TO THE NXT PLATFORM WERE IDENTIFIED. UPON RETURN TO THE STATION, THE EVENT LOG WAS DOWNLOADED VIA USB FROM THE NXT PLATFORM AND SHOWED FAULT 1210 (FAULT_MOTOR_SENSOR_LOW_DURING_COMPRESS).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24600039 ↗
• MalfunctionMar 11, 2026Visual Prompts will not Clear

  A 77-YEAR-OLD MALE PATIENT EXPERIENCED CARDIAC ARREST. UPON APPLICATION OF THE NXT PLATFORM (SN (B)(6)), A YELLOW WARNING TRIANGLE INDICATOR APPEARED IMMEDIATELY AFTER POWER-ON, AND THE DEVICE SUBSEQUENTLY SHUT DOWN. THE PATIENT'S STATUS INFORMATION WAS REQUESTED BUT THE CUSTOMER DID NOT PROVIDE A RESPONSE. FOLLOWING THE INCIDENT, IT WAS OBSERVED THAT THE PIN SECURING THE NXT BAND TO THE PLATFORM WAS NOT PROPERLY ATTACHED TO THE LEFT-SIDE SPOOL. ADDITIONALLY, THE LEFT-SIDE SPOOL WAS ROTATED OUT OF ALIGNMENT COMPARED TO THE SPOOL ON THE RIGHT SIDE. ATTEMPTS TO RETURN THE SPOOL TO ITS CORRECT READY POSITION WERE UNSUCCESSFUL.

  Patient problems: Insufficient Information

  MAUDE report 24574778 ↗
• MalfunctionMar 10, 2026Display or Visual Feedback Problem; Temperature Problem

  THE CUSTOMER REPORTED THAT DURING THE RESUSCITATION ATTEMPT, THE AUTOPULSE NXT PLATFORM (SN (B)(6) DISPLAYED A YELLOW ALERT TRIANGLE LED AND STOPPED COMPRESSIONS. THE CREW TURNED THE PLATFORM OFF AND BACK ON AGAIN, AND IT STARTED WORKING AND COMPRESSED FOR ANOTHER APPROXIMATELY 15 MINUTES. THE CREW REPORTED FEELING WARM AIR COMING FROM THE VENTS. THE NXT PLATFORM WAS ON THE STRETCHER, ON TOP OF THE BLANKETS, AND THE VENTS WERE MONITORED TO STAY CLEAR DURING THE REPORTED EVENT. PER THE CUSTOMER, THE DEVICE STOPPED DUE TO A HIGH-TEMPERATURE FAULT. NO CONSEQUENCES OR IMPACTS ON THE PATIENT. NO SAFETY ISSUES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24560931 ↗
• MalfunctionMar 5, 2026Use of Device Problem

  THE CUSTOMER REPORTED THAT DURING A DEMO, THEY PLACED A TORSO MANIKIN ON THE AUTOPULSE NXT PLATFORM (SN (B)(6)). THE PLATFORM AND NXT BAND (LOT # UNKNOWN) KEPT PROVIDING COMPRESSIONS; HOWEVER, THE BAND TWISTED ON ITS OWN. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24527306 ↗
• MalfunctionMar 2, 2026Use of Device Problem

  THE CUSTOMER REPORTED THAT THE AUTOPULSE NXT PLATFORM (SN: (B)(6) STOPPED DURING COMPRESSION AND WOULDN'T RESTART. NO FURTHER INFORMATION WAS PROVIDED. IT IS UNKNOWN WHEN THE PROBLEM OCCURRED. HOWEVER, PATIENT USE INFORMATION WAS REQUESTED, BUT NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 24484560 ↗
• MalfunctionFeb 26, 2026Use of Device Problem

  THE CUSTOMER REPORTED THAT WHEN THEY ARRIVED AT WORK, THEY DISCOVERED THE AUTOPULSE NXT BATTERY (SN UNKNOWN) WAS STUCK IN THE AUTOPULSE PLATFORM (SN (B)(6)) BECAUSE THE BATTERY'S FINGER D-RING HAD POPPED OUT. IT IS UNKNOWN WHEN THE PROBLEM OCCURRED. HOWEVER, PATIENT USE INFORMATION WAS REQUESTED, BUT NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24461672 ↗
• MalfunctionFeb 25, 2026Use of Device Problem

  THE CUSTOMER REPORTED THE AUTOPULSE NXT PLATFORM (SN (B)(6)) WAS PAUSED TO CHECK FOR RHYTHM DURING AN EVENT, HOWEVER THE PLATFORM WILL NOT START AFTER THE PAUSE. PATIENT'S STATUS INFORMATION WAS REQUESTED BUT THE CUSTOMER DID NOT PROVIDE A RESPONSE.

  Patient problems: Insufficient Information

  MAUDE report 24448752 ↗
• MalfunctionFeb 24, 2026Display or Visual Feedback Problem; Use of Device Problem; Audible Prompt/Feedback Problem

  THE CUSTOMER REPORTED DURING INITIAL TRAINING WITH ZOLL, THE AUTOPULSE NXT PLATFORM (SN (B)(6)) DID TWO COMPRESSIONS, THEN THE NXT BAND STOPPED AND ALL THE LIGHTS ON THE USER CONTROL PANEL ON THE PLATFORM WERE ILLUMINATED. AN AUDIBLE ALARM WAS OBSERVED. THE ZOLL TRAINERS TROUBLESHOOTED THE BOARD AND THE BAND; IT FAILED A COUPLE MORE TIMES. THE NXT BAND AND BATTERY WERE REPLACED. AFTER SEVERAL MORE ATTEMPTS, THEY WERE ABLE TO GET THE BOARD TO FUNCTION. THIS PLATFORM HAD NOT YET BEEN PLACED INTO SERVICE. NO SUSPECTED ISSUE WITH THE NXT BAND OR BATTERIES. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24437097 ↗
• MalfunctionFeb 10, 2026Use of Device Problem; Key or Button Unresponsive/not Working

  DURING ADDITIONAL TRAINING SESSIONS WITH THE AUTOPULSE NXT PLATFORM (SN (B)(6) PERFORMED BY ZOLL TERRITORY MANAGER AND CLINICAL DEPLOYMENT TEAM, WHEN THE RED STOP BUTTON ON THE LEFT-SIDE USER CONTROL PANELS WAS PRESSED, IT DID NOT STOP COMPRESSIONS. ADDITIONALLY, THE COMPRESSION MODE BUTTON WOULD NOT RESPOND, AND THE OTHER BUTTONS FAILED TO FUNCTION PROPERLY. THERE WAS NO ALERT LIGHT PRESENT. NO PATIENT INVOLVEMENT. THE CUSTOMER STATED THAT THEIR INSTRUCTOR, WHO USED THE NXT PLATFORM THE DAY BEFORE THIS REPORTED ISSUE WAS NOTICED, AND THEY BELIEVE THE NXT PLATFORM WAS WORKING CORRECTLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24310497 ↗