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); Noise, Audible (3273)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/29/2026
Type of Reportable Event	Malfunction

• 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: 50332875
• Report Number: 3010617000-2026-00522
• Device Sequence Number: 5431387
• Product Code: DRM
• UDI-Device Identifier: 00849111003384
• UDI-Public: 00849111003384
• Combination Product (Y/N): N
• 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: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/16/2026

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: 08/05/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 08/26/2026
• Initial Report FDA Received Date: 08/19/2026
• Supplement Report FDA Received Date: 09/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/04/2026
• 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