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	Insufficient Information (4580)
Date of Event	02/02/2026
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 platform for investigation.A follow-up report will be submitted if and when the product is returned, and the investigation has been completed.
Event or Problem Description
The customer reported that the autopulse nxt platform (sn: (b)(6) stopped during compression and wouldn't restart.No further information was provided.It is unknown when the problem occurred.However, patient use information was requested, but no additional information was provided.
Additional Manufacturer Narrative
The customer's complaint that the autopulse nxt platform (sn (b)(6) stopped during compression and wouldn't restart was confirmed based on the archive data review, but not during the functional testing.Based on the archive data, the nxt platform stopped compressions due to fault code 1210 (motor current too low during compression hold), likely because the platform detected the absence of a patient, indicated by the band being open, and did not compress.The fault code was not replicated during the functional testing, and the nxt platform functioned as intended.The archive data indicated that the nxt platform was used for treatment on a medium-stiffness patient for 12 minutes (957 compressions).The session ended due to fc 1210 - motor current too low during compression hold.The nxt platform passed the preliminary functional testing with no issues.The nxt platform was further tested using the mztf (medium zoll test fixture) until the battery was completely discharged, with no faults or errors detected.The fault code was not replicated during the functional testing, and the nxt platform functioned as intended.Following the service, the autopulse nxt platform passed the final tests without issues.

• 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 ; 4084192347
• MDR Report Key: 24484560
• Report Number: 3010617000-2026-00119
• Device Sequence Number: 20109815
• Product Code: DRM
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/07/2026

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: 02/02/2026
• Supplement Date Received by Manufacturer: 06/12/2026
• Initial Report FDA Received Date: 03/02/2026
• Supplement Report FDA Received Date: 07/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/02/2023
• 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