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

Model Number	MODEL 200
Medical Device Problem Code	Battery Problem (2885)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/09/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
For g4: pma/510(k): premarket submission number not available/not released.Zoll has received the autopulse nxt li-ion battery in the complaint for investigation.A supplemental report will be filed when the investigation has been completed.
Event or Problem Description
The customer reported the autopulse nxt li-ion battery (sn (b)(6) is bad.The status leds on the battery and the charger displayed green leds after charging.However, when the battery is inserted into the autopulse nxt platform, the triangle alert indicator lights up upon powering on.When the battery was rotated out, the indicator was not illuminated.This was noticed during shift check.No patient involvement.
Additional Manufacturer Narrative
The complaint that upon powering on, the triangle alert indicator lights on the autopulse nxt platform illuminated when using the fully charged autopulse nxt li-ion battery (sn (b)(6) was not confirmed during functional testing or archive data review.No device malfunction was observed during testing, and the battery functioned as intended.Upon visual inspection, no physical damage was observed.The status leds of the battery showed four green leds.The battery passed charging in a known good nxt charger, and the status leds on the battery showed four steady green lights after the successful charging attempt.The battery was tested in a known-good ap nxt platform and successfully powered the platform for 34 minutes.The reported complaint was not reproduced.

• 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: kimthoa sackrison ; 2000 ringwood ave; san jose, CA 95131
• MDR Report Key: 24264572
• Report Number: 3010617000-2026-00059
• Device Sequence Number: 13443231
• Product Code: DRM
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 03/04/2026

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
• Date Returned to Manufacturer: 01/27/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/09/2026
• Supplement Date Received by Manufacturer: 02/20/2026
• Initial Report FDA Received Date: 02/04/2026
• Supplement Report FDA Received Date: 03/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/28/2025
• 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