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

Model Number	Model 200
Medical Device Problem Code	Visual Prompts will not Clear (2281)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/25/2026
Type of Reportable Event	Malfunction
Event or Problem Description
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.
Additional Manufacturer Narrative
For g4: pma/510(k): premarket submission number not available/not released.The autopulse nxt platform involved in the reported complaint will not be returned for evaluation because the customer conducted a very long bench test on the nxt platform using a manikin and noted no errors or unusual heat on the exhaust side.At this point, the customer assumes something interfered with airflow on the platform during the reported event.The platform has been returned to service for clinical use, and the customer will continue to monitor.The customer has provided the archive data from the autopulse nxt platform.Zoll is reviewing the archive data.A follow-up report will be submitted once the archive data review is complete.

• 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: 50841082
• Report Number: 3010617000-2026-00585
• Device Sequence Number: 10262789
• Product Code: DRM
• UDI-Device Identifier: 00849111003384
• UDI-Public: 00849111003384
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 09/21/2026

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: 08/25/2026
• Initial Report FDA Received Date: 09/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/14/2025
• 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