MAUDE Adverse Event Report: ZOLL CIRCULATION, INC. AUTOPULSE LI-ION BATTERY¿; SECONDARY BATTERY

Model Number	100
Medical Device Problem Code	Battery Problem (2885)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/07/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zoll has not received the autopulse li-ion battery for investigation.A follow-up report will be submitted when the product is returned, and the investigation has been completed.
Event or Problem Description
As reported, the autopulse li-ion battery (sn (b)(6)) was observed to be swollen, which made insertion into the autopulse platform difficult.It is unknown when the problem occurred.However, patient use information was requested but no additional information was provided.
Additional Manufacturer Narrative
The autopulse li-ion battery involved in the reported complaint will not be returned for evaluation, as the customer was requested to dispose of it due to its current condition.Therefore, a physical investigation could not be performed, and the root cause could not be determined.Correction: b3, date of event, h6, type of investigation additional information: b5, describe event or problem, h4, device manufacture date, h11, additional manufacturer narrative.
Event or Problem Description
During the shift check, the autopulse li-ion battery (sn (b)(6) was observed to be swollen, which made insertion into the autopulse platform difficult.The charger showed a charged/ready status with no failure indicated after the charge attempt.When the battery status button was pressed, the green leds lit, confirming a full charge.The platform was confirmed to be functional when used with another battery.No patient involvement.

• Brand Name: AUTOPULSE LI-ION BATTERY¿
• Common Device Name: SECONDARY BATTERY
• 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 ; 4084192347
• MDR Report Key: 23954679
• Report Number: 3010617000-2026-00006
• Device Sequence Number: 5610966
• Product Code: DRM
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K112998
• 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): 01/22/2026

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: 100
• Device Catalogue Number: 8700-0752-01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/09/2025
• Supplement Date Received by Manufacturer: 01/05/2026
• Initial Report FDA Received Date: 01/05/2026
• Supplement Report FDA Received Date: 01/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/27/2025
• 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