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	06/20/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported complaint of the autopulse platform (sn (b)(6) displayed the "system error, out of service, revert to manual cpr" error message was confirmed during initial functional testing and archive data review.The root cause of the system error was due to the failure of the processor board, likely attributed to the device's aging; the device's life expectancy is 5 years.The autopulse platform was manufactured in april 2013 and is over 12 years old.The archive data review showed the occurrence of the system error, user advisory (ua) 136 (internal parameter corrupted) error message.During the initial functional test, the platform displayed a "system error, out of service, revert to manual cpr" error message during power on, thus confirming the reported complaint.To remedy the error message, the failed processor board needs to be replaced.The last autopulse 1.1 was manufactured in 2009.As of july 2016, zoll announced the end of life for autopulse 1.1.Many important components used in autopulse 1.1 are no longer available, further restricting our ability to service.Zoll offered the customer a replacement device.Therefore, no service was performed, and the autopulse platform will be scrapped at zoll.Historical complaints were reviewed for service information related to the reported complaint, and there was no previous history of complaints reported for the autopulse platform with serial number (b)(6).
Event or Problem Description
During the shift check, the autopulse platform (sn (b)(6) repeatedly displayed the "system error, out of service, revert to manual cpr" message.No patient involvement.

• 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: 22503386
• Report Number: 3010617000-2025-00471
• Device Sequence Number: 18298863
• Product Code: DRM
• UDI-Device Identifier: 00849111000277
• UDI-Public: 00849111000277
• Combination Product (Y/N): N
• Initial Reporter State: NH
• 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): 07/14/2025

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: 8700-0700-01-66
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/20/2025
• Initial Report FDA Received Date: 07/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/05/2013
• 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