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	09/10/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported the autopulse platform (sn: (b)(6) displayed "system error, out of service, revert to manual cpr".Also, the bottom back case is cracked.This was noticed during a regular check.No patient involvement.
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 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 august 2008 and is over 17 years old.The reported complaint that the bottom back case is cracked was confirmed during visual inspection.The front enclosure was cracked in the front-end area.The probable root cause for the observed physical damage was mishandling.The front enclosure needs to be replaced to remedy the complaint.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.Ap vision indicated system error - 136 (invalid parameters block).The processor board needs to be replaced to remedy the system error.Waiting for customer approval for repair.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: 50870650
• Report Number: 3010617000-2026-00622
• Device Sequence Number: 9425989
• Product Code: DRM
• UDI-Device Identifier: 00849111000017
• UDI-Public: 00849111000017
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 09/23/2026

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
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/21/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/10/2026
• Initial Report FDA Received Date: 09/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/05/2008
• 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