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	12/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
For g4: pma/510(k): premarket submission number not available/not released.Zoll has not received the autopulse nxt band in the complaint for investigation.A supplemental report will be filed if and when the product is returned and investigation has been completed.
Event or Problem Description
The customer reported they were dispatched to a cardiac arrest.The autopulse nxt platform (sn (b)(6)) was applied to the approximately 52-year-old, 250-270-pound male patient after several minutes.The med unit began transport to the pci facility.After approximately 20 minutes, the platform suddenly stopped on its own.No one was touching the controls at the time.According to the customer, no warning lights were noted.The green start button was pressed and the platform resumed as normal.After approximately 3 mins, a battery change occurred, and the platform resumed normal operations.There is no suspected battery malfunction.After 3-5 minutes, the nxt band (lot unknown) ripped off the patient.The crew continued with manual cpr and the nxt band was attempted to be reattached unsuccessfully.The patient was kept on the platform but there were no further attempts to use the platform.Manual cpr was performed until hand off at the hospital.No consequences or impact on the patient.After the call was completed, inspection of the nxt band found that the velcro ripped partially off.The band ripped/tore mid-way between the connection to board and largest part of the band.

• 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: 23930688
• Report Number: 3010617000-2025-00945
• Device Sequence Number: 21085682
• Product Code: DRM
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 12/30/2025

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: 8700-001017
• Device Lot Number: UNKNOWN
• 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: 12/10/2025
• Initial Report FDA Received Date: 12/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 52 YR
• Patient Sex: Male
• Patient Weight: 113 KG