MAUDE Adverse Event Report: ZOLL CIRCULATION, INC. AUTOPULSE NXT RESUSCITATION SYSTEM; CARDIAC RESUSCITATOR, LINE-POWERED

Model Number	MODEL 200
Medical Device Problem Codes	Device Emits Odor (1425); Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/03/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
For g4: pma/510(k): premarket submission number not available/not released the reported complaint that the autopulse nxt platform (sn (b)(6) emitted a burnt electrical odor was verified during functional testing.However, after performing compression testing, the odor was noticeably reduced.The burning smell is primarily due to oil residue burning off from the motor as it heats up.The customer stated that the platform shut off when the crew smelled the odor.This was not confirmed in either the archive data or functional testing.The autopulse nxt platform operated correctly and performed as intended.Reviewing the archive data indicated that the platform was used for a treatment session lasting 19 minutes.During this session, 1502 compressions were delivered to a patient with a stiff chest and hard to compress.The session ended when the internal motor temperature exceeded the thermal limit of 110 °c, triggering fault 1290 (fault_analog_motor_over_temp).This fault stopped the compressions, and the alert yellow triangle indicator lit up.The archive data did not show any instances of the platform shutting off on its own.The autopulse nxt platform passed the preliminary functional testing without faults or errors.During compression testing, a burning odor was observed, confirming the customer's complaint.The platform was subsequently subjected to compression testing using the large resuscitation test fixture (lrtf) with two batteries, which resulted in a reduction of residual motor oil.A significant odor reduction was observed during use of the second battery.Following service, the autopulse nxt platform passed all testing criteria.
Event or Problem Description
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.

• 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 ; 4084192347
• MDR Report Key: 24709167
• Report Number: 3010617000-2026-00185
• Device Sequence Number: 10046927
• Product Code: DRM
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 03/26/2026

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/03/2026
• Initial Report FDA Received Date: 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/10/2024
• 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