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	Insufficient Information (4580)
Date of Event	08/27/2026
Type of Reportable Event	Malfunction
Event or Problem Description
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.
Additional Manufacturer Narrative
For g4: pma/510(k): premarket submission number not available/not released the autopulse nxt platform (sn (b)(6)) involved in the reported complaint was not returned to zoll for evaluation.However, the platform's archive files were reviewed and showed that the autopulse nxt platform was operating normally, with no evidence of a malfunction.According to the archive log review, the autopulse nxt platform was used in active operation on (b)(6) 2026 for 20 minutes and 53 seconds, during which 1,634 compressions were delivered.During the treatment, alert 120 (alert_analog_motor_temp) was generated when the motor temperature reached 100°c.The platform continued delivering compressions until the internal enclosure temperature increased to 59.5°c, triggering fault code 1270 (fault_analog_patient_over_temp).At that point, the nxt platform stopped compressions, and the alert yellow triangle indicator illuminated, confirming the reported complaint.While the platform remained in an idle state, the motor temperature continued to increase and reached 110°c, triggering fault code 1290 (fault_analog_motor_over_temp).The review determined that the platform unexpectedly reached both the patient and motor temperature limits.There is a possibility that the exhaust vents may have been blocked during treatment, restricting airflow and contributing to the elevated temperatures.

• 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: kim thoa sackrison ; 2000 ringwood ave.; san jose, CA 95131 ; +1(408)419-2347
• MDR Report Key: 50893052
• Report Number: 3010617000-2026-00586
• Device Sequence Number: 10759007
• Product Code: DRM
• UDI-Device Identifier: 00849111003384
• UDI-Public: 00849111003384
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 09/24/2026

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/27/2026
• Initial Report FDA Received Date: 09/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/18/2025
• 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