MAUDE Adverse Event Report: ZOLL CIRCULATION, INC. AUTOPULSE LI-ION BATTERY; CARDIAC RESUSCITATOR, LINE-POWERED

Model Number	MODEL 200
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/05/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that when they arrived at work, they discovered the autopulse nxt battery (sn unknown) was stuck in the autopulse platform (sn (b)(6) because the battery's finger d-ring had popped out.It is unknown when the problem occurred.However, patient use information was requested, but no additional information was provided.
Additional Manufacturer Narrative
For g4: pma/510(k): premarket submission number not available/not released.Zoll has not received the autopulse nxt lithium-ion battery 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 when they arrived at work, they discovered the autopulse nxt battery (sn (b)(6) was stuck in the autopulse nxt platform (sn (b)(6) because the battery's finger d-ring had popped out.No patient involvement.Zoll field technical service representative visited the customer site and removed the stuck nxt battery.A new battery was installed in the autopulse, and it slid in and out as it should.The customer put the autopulse nxt platform back into service.
Additional Manufacturer Narrative
Sections b5, h2, h6 codes, and h11 are updated.The reported complaint that the autopulse nxt battery (sn (b)(6) was stuck in the autopulse nxt platform was confirmed based on visual inspection.The root cause of the reported complaint was the broken d-ring latch, which prevented the customer from removing the battery from the platform's battery compartment.The root cause of the detached d-ring was a weak spot in the finger ring locking mechanism, which caused the finger ring to rotate past the lock/unlock mark.Because the latch assembly was detached from the battery, it could not be inserted into or removed from a known-good nxt platform.Therefore, further testing was not performed due to the verified physical damage.
Additional Manufacturer Narrative
Sections d4 (serial #) was updated.
Additional Manufacturer Narrative
H6 component code (g) was added.

• Brand Name: AUTOPULSE LI-ION BATTERY
• 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: 24461673
• Report Number: 3010617000-2026-00142
• Device Sequence Number: 10052104
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 04/03/2026

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: 8700-001012
• 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: 02/05/2026
• Supplement Date Received by Manufacturer: 03/05/2026; 03/31/2026; 04/03/2026
• Initial Report FDA Received Date: 02/26/2026
• Supplement Report FDA Received Date: 03/31/2026; 03/31/2026; 04/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/10/2024
• 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