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)
Date of Event	02/24/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported complaint that the autopulse platform (sn (b)(6) displayed "system error, out of service, revert to manual cpr" was confirmed during functional testing.The platform's archive data could not be downloaded; however, the platform and diagnostic service pc communicated, and apvision3 software confirmed a system error - 136 (internal parameter corrupted).The root cause of the system error was a defective processor board (pca), likely attributed to the device's aging.The device's life expectancy is 5 years.The autopulse platform was manufactured in april 2014 and is almost 12 years old.The archive data could not be downloaded because the backup memory (non-volatile ram) parameters had been corrupted due to the defective processor board.The autopulse platform failed initial functional testing because it displayed "system error, out of service, revert to manual cpr" upon powering up, confirming the reported complaint.Technical investigation identified the defective processor board as the cause, and it was replaced to remedy the fault.Following service, the autopulse platform passed all testing criteria.Historical complaints were reviewed for service information related to the reported complaint, and no similar complaints were reported for the autopulse platform with serial number (b)(6).
Event or Problem Description
The customer reported that the autopulse platform (sn (b)(6) displayed "system error, out of service, revert to manual cpr." no further information was provided.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: kim thoa sackrison ; 2000 ringwood ave.; san jose, CA 95131 ; 4084192347
• MDR Report Key: 24634538
• Report Number: 3010617000-2026-00155
• Device Sequence Number: 12936201
• Product Code: DRM
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/18/2026

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: 8700-0700-01-66
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/24/2026
• Initial Report FDA Received Date: 03/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/24/2014
• 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