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

Model Number	Model 200
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/02/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that during a patient call, the autopulse nxt platform (sn (b)(6) stopped delivering compressions.The customer stated that it is unknown whether the nxt platform displayed any alert when it stopped delivering compressions.The customer mentioned that the nxt platform ventilation openings were not blocked by clothing or the patient, but there was a hygiene barrier on the platform.The customer suspected that the platform's hygiene barrier may not have allowed sufficient airflow to the fan and that the batteries may have become hot.The customer didn't report any complaint related to the batteries used during the reported event and stated that the batteries have been functioning properly since then.The customer did not report any harm, injury, or death and stated that there was minimal impact on the patient, as they just resumed manual cpr.
Additional Manufacturer Narrative
For g4: pma/510(k): premarket submission number not available/not released zoll has not received the autopulse nxt platform in complaint for investigation.A follow-up report will be filed if and when the product is returned and investigation has been completed.

• 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: 50941677
• Report Number: 3010617000-2026-00602
• Device Sequence Number: 16141452
• Product Code: DRM
• UDI-Device Identifier: 00849111003384
• UDI-Public: 00849111003384
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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): 09/29/2026

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: 09/02/2026
• Initial Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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