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

Model Number	MODEL 200
Medical Device Problem Codes	Use of Device Problem (1670); Key or Button Unresponsive/not Working (4063)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/21/2026
Type of Reportable Event	Malfunction
Event or Problem Description
During additional training sessions with the autopulse nxt platform (sn (b)(6) performed by zoll territory manager and clinical deployment team, when the red stop button on the left-side user control panels was pressed, it did not stop compressions.Additionally, the compression mode button would not respond, and the other buttons failed to function properly.There was no alert light present.No patient involvement.The customer stated that their instructor, who used the nxt platform the day before this reported issue was noticed, and they believe the nxt platform was working correctly.
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.
Additional Manufacturer Narrative
Correction to h11 first paragraph: the reported complaint that the compression mode button on the autopulse nxt platform (sn (b)(6)) was unresponsive was confirmed through archive data review and visual-functional inspection.The root cause of the reported complaint was a loose cap beneath the compression mode button that was not properly secured to the ui board's mechanical switch.
Additional Manufacturer Narrative
Sections d9, h3, h4, and h6 codes were updated.The reported complaint that the compression mode button on the autopulse nxt platform (sn (b)(6) was unresponsive was confirmed through archive data review and visual-functional inspection.The reported complaint that pressing the red stop button on the left-side user control panel did not stop compressions was not confirmed during testing at zoll.Additionally, the reported issue that other buttons failed to function properly was not confirmed.Aside from the compression mode button, all remaining buttons on the autopulse nxt platform functioned as intended.Review of the archive logs identified occurrences of fault code 260 (alert_key_stuck_lt_ui) on the event date.This alert indicates a stuck button on the left-side user control panel, confirming the reported complaint that the compression mode button was not responding.The autopulse nxt platform successfully passed preliminary functional testing with no faults or errors observed.During further visual-functional inspection, the compression mode button on the left user control panel was found to be non-functional.Upon opening the bottom enclosure and removing the left-side ui board, it was observed that the cap beneath the compression mode button was slightly loose and not securely seated on the board's mechanical switch.This caused the compression mode button to get stuck and not release properly.The cap was reinstalled firmly on the ui board and verified that all the mode buttons' mechanical switches were pressed and released correctly.The compression mode button became fully functional.Also, all other buttons were tested and confirmed to be working as intended.Following service, the autopulse nxt platform passed all testing criteria.Historical complaints were reviewed for service information related to the reported complaint, and there was no previous history of complaints reported for the autopulse nxt platform with serial number (b)(6).

• 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: 24310497
• Report Number: 3010617000-2026-00090
• Device Sequence Number: 20229892
• Product Code: DRM
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/12/2026

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/21/2026
• Supplement Date Received by Manufacturer: 02/19/2026; 03/12/2026
• Initial Report FDA Received Date: 02/10/2026
• Supplement Report FDA Received Date: 03/12/2026; 03/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/19/2025
• 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