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	11/08/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
For g4: pma/510(k): premarket submission number not available/not released the reported complaint that the right-side band went slack on the autopulse nxt platform (sn (b)(6) while the left-side band shifted and delivered compressions only to the left side of the chest was not confirmed during functional testing.The autopulse nxt platform functioned appropriately and performed as intended.The most likely cause of the reported problem is that the right-side pin of the band was not fully inserted into the band belt spool, resulting in band slack.The archive log file contained no recorded faults or alerts near the reported event date.The autopulse nxt platform passed the preliminary functional testing without errors.The platform was tested using the large resuscitation test fixture (lrtf) with two batteries until completely discharged, with no faults or errors detected.The nxt platform was further tested with a medium zoll torso fixture (mztf) until the battery was completely discharged, with no faults or errors detected.The autopulse platform functioned appropriately and performed as intended.Following service, the autopulse nxt platform passed all testing criteria.
Event or Problem Description
The customer reported that the crew attempted to deploy the autopulse nxt platform (sn (b)(6) on a patient.The customer stated that, to the best of their knowledge, the nxt band (lot # unknown) was correctly attached to the nxt platform.Upon initial inspection, both sides of the nxt band appeared to be in good working condition.The nxt platform was used on a concrete surface, and no audible alerts or visible faults were displayed on the control panel when it was powered on.According to the customer, the band initiated correctly; however, shortly thereafter, the band on the patient's right side went slack.Simultaneously, the left-side band shifted and began contracting irregularly, delivering compressions solely to the left side of the patient's chest.No one on scene noticed any warnings or lights on the platform's control panel.The use of the nxt platform was discontinued, and manual chest compressions were initiated.The crew inspected the nxt platform and attempted to redeploy the device, but the same issue occurred.After a third unsuccessful attempt, manual compressions were continued for the remainder of the encounter.No consequences or impacts on the patient.The crew on scene did not have a replacement band available, so the band was not replaced.Post-incident, during decontamination of the device back at the station, it was noticed that the right side of the nxt band appeared shredded/torn.The band was subsequently disposed of due to biohazard concerns from the call.The nxt platform was tested with another nxt band and worked without issue.

• 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 ; 4084192347
• MDR Report Key: 23721399
• Report Number: 3010617000-2025-00846
• Device Sequence Number: 10100575
• Product Code: DRM
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 12/04/2025

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: 8700-001010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/28/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/10/2025
• Initial Report FDA Received Date: 12/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/11/2025
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown