MAUDE Adverse Event Report: Zoll Circulation, Inc. AutoPulse NXT Resuscitation System; Cardiac resuscitator, line-powered

Model Number	Model 200
Medical Device Problem Codes	Use of Device Problem (1670); Visual Prompts will not Clear (2281)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
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.
Additional Manufacturer Narrative
For g4: pma/510(k): premarket submission number not available/not released.No safety issue was reported.The customer's complaint that the autopulse nxt platform (sn (b)(6)) illuminated an alert yellow triangle led and emitted smoke was confirmed during the functional testing and the archive data review.The root cause of the reported complaint was fan failure.Investigation revealed that the nxt platform was exposed to a considerable amount of blood, and the fluid penetrated the fan and shorted the fan electronics, causing smoke and fan failure.The log file indicated the occurrence of fault code 1300 (fault_no_fans_fun): the fan is not functional, confirming the complaint.Based on the log data review, the nxt platform was used for the treatment of 12 minutes and 2 seconds (865 compressions) on the reported event date.The session ended due to fault code 1300, and the alert yellow triangle led illuminated.The user powered off and then powered on the nxt platform multiple times.The alert yellow triangle led continues to illuminate each time the nxt platform was turned on.The nxt platform detected that the fan was not functional.The nxt platform failed functional testing because the alert yellow triangle led flashed on power-on, confirming the complaint.Further inspection revealed that the fan was not turned on when the nxt platform was powered on.Upon opening the bottom enclosures, traces of blood/fluid ingress were found at the venting/baffle area.The nxt platform was exposed to a considerable amount of blood, likely with the fan running.Fluid penetrated the fan and shorted out the fan electronics, emitting smoke.The fan assembly was replaced to address the reported complaint.Bio-cleaning was performed to address the blood ingress.Following service, the autopulse nxt platform passed the final tests without issues.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).

• Brand Name: AutoPulse NXT Resuscitation System
• Common Device Name: Cardiac resuscitator, line-powered
• Manufacturer (Section D): Zoll Circulation, Inc.; 2000 ringwood ave.; san jose CA 95131
• Manufacturer (Section G): Zoll Circulation, Inc.; 2000 ringwood ave.; san jose CA 95131
• Manufacturer Contact: kimthoa sackrison ; 2000 ringwood ave.; san jose, CA 95131 ; +1(408)419-2347
• MDR Report Key: 50935010
• Report Number: 3010617000-2026-00594
• Device Sequence Number: 9498837
• Product Code: DRM
• UDI-Device Identifier: 00849111003384
• UDI-Public: 00849111003384
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/29/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: Model 200
• Device Catalogue Number: 8700-001070
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/18/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/01/2026
• Initial Report FDA Received Date: 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/26/2025
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown