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); 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	02/20/2026
Type of Reportable Event	Malfunction
Event or Problem Description
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.
Additional Manufacturer Narrative
For g4: pma/510(k): premarket submission number not available/not released the reported complaints that the autopulse nxt platform (b)(6) would not cinch down even with the bands in place, emitted an odor, and illuminated an alert yellow triangle indicator were not confirmed through archive data review or functional testing.The autopulse nxt platform functioned as intended.Review of the archive data revealed no errors or faults.The autopulse nxt platform successfully passed preliminary functional testing with no faults or errors.The reported burning odor is typically attributable to residual oil burning off the motor as it heats; however, no such odor was detected during testing.The platform underwent continuous testing using the large resuscitation test fixture (lrtf) with two nxt batteries, a process intended to further reduce any remaining oil residue within the motor.Following service, the autopulse nxt platform passed all testing criteria.

• 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: 24622871
• Report Number: 3010617000-2026-00162
• Device Sequence Number: 9068536
• Product Code: DRM
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 03/17/2026

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: 03/09/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/20/2026
• Initial Report FDA Received Date: 03/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/11/2025
• 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