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)
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 platform displayed the yellow alert triangle indicator during shift check (without compression) with autopulse nxt li-ion battery (sn (b)(6)).The battery was fully charged, all 4 green status leds.It is unknown what color led was displayed on the nxt charger during/after the last charge attempt.No fault occurred with another battery.There is no suspected malfunction with the charger.No patient involvement.
Additional Manufacturer Narrative
The complaint that the autopulse nxt platform displayed the yellow alert triangle indicator with 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.No major errors or anomalies were noted in the battery archive.The battery passed charging in a known good nxt charger.The battery was tested several times and it works without problems.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: 24381574
• Report Number: 3010617000-2026-00089
• Device Sequence Number: 10490629
• Product Code: DRM
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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
• Report Date (Section B): 03/26/2026

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: 01/26/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/26/2026
• Supplement Date Received by Manufacturer: 03/16/2026
• Initial Report FDA Received Date: 02/18/2026
• Supplement Report FDA Received Date: 03/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/16/2025
• 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