MAUDE Adverse Event Report: ZOLL CIRCULATION, INC AUTOPULSE NXT RESUSCITATION SYSTEM; CARDIAC RESUSCITATOR, LINE-POWERED

Model Number	MODEL 200
Medical Device Problem Codes	Display or Visual Feedback Problem (1184); Use of Device Problem (1670); Audible Prompt/Feedback Problem (4020)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/29/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported during initial training with zoll, the autopulse nxt platform (sn (b)(6)) did two compressions, then the nxt band stopped and all the lights on the user control panel on the platform were illuminated.An audible alarm was observed.The zoll trainers troubleshooted the board and the band; it failed a couple more times.The nxt band and battery were replaced.After several more attempts, they were able to get the board to function.This platform had not yet been placed into service.No suspected issue with the nxt band or batteries.No patient involvement.
Additional Manufacturer Narrative
For g4: pma/510(k): premarket submission number not available/not released.The complaint that the autopulse nxt platform (sn (b)(6)) did two compressions, then the nxt band stopped and all the lights on the user control panel on the platform were illuminated and an audible alarm was observed was confirmed based on the archive review but not during functional testing.According to the archive, fault 1097 was observed around the event date.However, during testing, the platform performed as intended without faults or errors.Based on the archive log review, the platform was not operational due to multiple fault 1097s around the event date (the motor encoder is logged, and the attention led flashes), confirming the reported complaint.This fault relates to a software issue and can be resolved by performing a power cycle or gently pulling the band to nudge the motor.The autopulse nxt platform passed the preliminary functional test without any fault or error.The platform was tested using the mztf (medium zoll test fixture) with no faults or errors detected.The autopulse functioned appropriately and performed as intended.The customer reported complaint was not reproduced.Since the customer has received the replacement platform, the autopulse nxt platform will be stored for future refurbishment sale order requests.

• 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: 24437097
• Report Number: 3010617000-2026-00103
• Device Sequence Number: 10244692
• Product Code: DRM
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 02/24/2026

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/29/2026
• Initial Report FDA Received Date: 02/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/22/2025
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown