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	08/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zoll has not received the platform for investigation.A follow-up report will be submitted when the product is returned, and the investigation has been completed.
Event or Problem Description
During the shift check, the autopulse platform (sn (b)(6) displayed "system error, out of service, revert to manual cpr".No patient involvement.
Additional Manufacturer Narrative
The customer's complaint that the autopulse platform (sn (b)(6)) displayed a "system error, out of service, revert to manual cpr" message was confirmed during the functional testing and the archive data review.The root cause of the reported system error was a failed processor board, likely attributed to the device's aging.The device's life expectancy is 5 years.The autopulse platform was manufactured in february 2010 and is over 15 years old.The archive data could not be downloaded due to a failed processor board.The platform and diagnostic service pc were able to communicate momentarily, and apvision3 software confirmed a system error 136 (internal parameter corrupted), confirming the reported complaint.The autopulse platform failed functional testing due to a "system error, out of service, revert to manual cpr" displayed upon powering on, confirming the reported complaint.The parameters in backup memory have been corrupted due to a failed processor board.The processor board was replaced to remedy the reported system error.Following the service, the autopulse platform passed the run-in and final tests without any faults or errors.Historical complaints were reviewed for service information related to the reported complaint, and no similar complaint was reported for the autopulse platform with sn (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: 23034111
• Report Number: 3010617000-2025-00625
• Device Sequence Number: 18562573
• 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): 10/06/2025

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: 8700-0730-01-66
• 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: 08/18/2025
• Supplement Date Received by Manufacturer: 09/12/2025
• Initial Report FDA Received Date: 09/11/2025
• Supplement Report FDA Received Date: 10/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/11/2010
• 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