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	06/09/2025
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 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 initially reported that their autopulse nxt batteries either do not hold a full charge or are being drained by the nxt unit itself.The customer stated that during a recent patient call, a fully charged nxt battery (sn (b)(6)) was inserted into the autopulse nxt platform, but it had already dropped to half charge.When the crew attempted to replace it, the second nxt battery taken from the shelf was found to be completely depleted.Later, the customer clarified that they would be sending only nxt battery sn (b)(6) for investigation, as this is the only battery showing issues.The remaining batteries hold a full charge and now appear to be functioning normally.The customer confirmed that there were no adverse effects on the patient, as they had three nxt batteries available and were able to replace the problematic one with a fully charged battery.
Additional Manufacturer Narrative
Sections d9, h2, h3, and h4 were updated.The customer's reported complaint that the fully charged nxt battery (b)(6) dropped to half charge right after being inserted into the autopulse nxt platform was not confirmed during functional tests or archive data review.No device malfunction was observed during testing, and the nxt battery performed as expected.Review of the battery's archive data revealed no significant anomalies or errors.The nxt battery was successfully charged in a known-good nxt battery charger, with four steady green lights indicating full charge afterwards.It then powered a known-good nxt platform for 39 minutes.The reported issue was not replicated, and the nxt battery functions as intended.

• 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: 22421459
• Report Number: 3010617000-2025-00454
• Device Sequence Number: 17887394
• Product Code: DRM
• UDI-Device Identifier: 00849111002998
• UDI-Public: 00849111002998
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 08/05/2025

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: 06/13/2025
• Supplement Date Received by Manufacturer: 07/21/2025
• Initial Report FDA Received Date: 07/07/2025
• Supplement Report FDA Received Date: 08/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/03/2024
• 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