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	02/11/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that during a demo, they placed a torso manikin on the autopulse nxt platform (sn (b)(6)).The platform and nxt band (lot # unknown) kept providing compressions; however, the band twisted on its own.No patient involvement.
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.
Event or Problem Description
The customer reported that during a demonstration, a torso manikin was positioned in the center of the autopulse nxt platform (sn (b)(6), where the patient would be placed.The nxt band (lot #211836) was installed across the manikin's chest in the appropriate anatomical position.When the nxt platform started compressions, the band twisted on its own.The customer reported that the band initially took up on only one side.No alerts were displayed on the nxt platform during the event.The band had not been used in any prior demonstrations, and no visible damage or signs of deterioration were observed.When the same torso manikin was used with different nxt band(s), the nxt platform functioned as expected.No patient involvement.
Additional Manufacturer Narrative
Sections b5, d9, h3, h4, and h6 codes were updated.The reported complaint that the nxt band twisted on its own after the initiation of compressions with the autopulse nxt platform (sn (b)(6) was not confirmed during functional testing at zoll.The autopulse nxt platform functioned appropriately and performed as intended.Based on the archive log review, no fault or alert occurred during the event.The autopulse nxt platform successfully passed preliminary functional testing with no faults or errors.The nxt platform was tested using a zoll test band with the medium resuscitation test fixture (mrtf) until the battery was fully discharged.During testing, no band twisting was observed.The nxt platform successfully passed all testing with no issues.Following service, the autopulse nxt platform passed all testing criteria.

• 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: 24527306
• Report Number: 3010617000-2026-00125
• Device Sequence Number: 8439594
• Product Code: DRM
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 04/02/2026

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: 02/11/2026
• Supplement Date Received by Manufacturer: 03/09/2026
• Initial Report FDA Received Date: 03/05/2026
• Supplement Report FDA Received Date: 04/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/05/2024
• 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