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

Model Number	Model 200
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/11/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported the autopulse nxt platform (sn (b)(6) has band clip retention issues.The clips on the nxt band do not fasten securely to the platform and disengage when tension is applied.Multiple bands were testing with the same result.This was noticed during shift check.No patient involvement.
Additional Manufacturer Narrative
For g4: pma/510(k): premarket submission number not available/not released.Zoll has not received the autopulse nxt platform in the complaint for investigation.A supplemental 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: kimthoa sackrison ; 2000 ringwood ave; san jose, CA 95131
• MDR Report Key: 50892784
• Report Number: 3010617000-2026-00623
• Device Sequence Number: 10684561
• Product Code: DRM
• UDI-Device Identifier: 00849111003384
• UDI-Public: 00849111003384
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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
• Report Date (Section B): 09/24/2026

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: 09/11/2026
• Initial Report FDA Received Date: 09/25/2026
• 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