MAUDE Adverse Event Report: ZOLL CIRCULATION, INC. AUTOPULSE® RESUSCITATION SYSTEM; CARDIAC RESUSCITATOR, LINE-POWERED

Model Number	100
Medical Device Problem Code	Visual Prompts will not Clear (2281)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported complaint that the autopulse platform (sn (b)(6)) displayed "replace battery" error message even when fully charged batteries were placed was confirmed during the archive data review and the functional testing.According to the archive, the autopulse platform displayed user advisory (ua) 04 (battery charge state too low) multiple times and prompted a battery replacement.The root cause of the reported complaint was a failed processor board, likely attributed to the failed component.During the archive review, several ua04 messages were found, confirming the reported complaint.The autopulse platform failed functional testing due to the ua04 error message, confirming the customer's reported complaint.The failed processor board was replaced to remedy the issue.The platform was further subjected to a run-in test using the lrtf (large resuscitation test fixture), and the test passed without issue.Following the service, the autopulse platform passed the run-in test without any fault or error.The autopulse platform passed final testing without any faults or errors.Historical complaints were reviewed for service information related to the reported complaint, and no similar complaints were reported for the autopulse platform with sn (b)(6).B3, the date of the event is unknown.
Event or Problem Description
As reported, the autopulse platform (sn (b)(6)) displays a "replace battery" error message even when fully charged batteries were placed.It is unknown when the problem occurred.However, patient use information was requested, but no additional information was provided.

• Brand Name: AUTOPULSE® RESUSCITATION SYSTEM
• 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 ; 4084192347
• MDR Report Key: 24613313
• Report Number: 3010617000-2026-00136
• Device Sequence Number: 21292366
• Product Code: DRM
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K112998
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/16/2026

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: 8700-0740-10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/16/2026
• Initial Report FDA Received Date: 03/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/10/2020
• 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