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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/21/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported the autopulse platform (sn (b)(6) displayed the "system error, out of service, revert to manual cpr" error message.This was noticed during shift check.No patient involvement.
Additional Manufacturer Narrative
Zoll has not received the autopulse platform in the complaint for investigation.A supplemental report will be filed if and when the product is returned and investigation has been completed.
Additional Manufacturer Narrative
The reported complaint that the autopulse platform (sn (b)(6) displayed the "system error, out of service, revert to manual cpr" error message was confirmed based on the review of the archive and during functional testing.The root cause of the reported complaint was the failed processor board, likely attributed to the device's aging, the device life expectancy is 5 years.The autopulse platform was manufactured in feb 2008 and is over 17 years old.The archive data was unrecoverable due to the device failing the initialization (power on self test), due to the failure of the processor board.However, ap vision indicated system error - 136 (invalid parameters block), thus confirming the reported complaint.The processor board was replaced to remedy the archive issue.The autopulse platform failed initial functional testing due to the "system error, out of service, revert to manual cpr" error message displayed upon powering up the device, confirming the reported complaint.The failed processor board (pca) was replaced to remedy the system error.During service, the autopulse platform passed the run-in test without any fault or error.The autopulse passed the final testing without any fault or error.Historical complaints were reviewed for service information related to the reported complaint, and there were no similar complaints reported for autopulse with serial number (b)(6).

• 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
• MDR Report Key: 23058298
• Report Number: 3010617000-2025-00622
• Device Sequence Number: 8582348
• Product Code: DRM
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 10/08/2025

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: 100
• Device Catalogue Number: 8700-0700-01
• 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: 08/21/2025
• Supplement Date Received by Manufacturer: 09/16/2025
• Initial Report FDA Received Date: 09/15/2025
• Supplement Report FDA Received Date: 10/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/21/2008
• 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