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	02/19/2025
Type of Reportable Event	Malfunction
Event or Problem Description
During the shift check, the autopulse platform (sn (b)(6)) displayed the "system error, out of service, revert to manual cpr" message during the device start-up.No patient involvement.
Additional Manufacturer Narrative
The reported complaint of the autopulse platform (sn (b)(6)) displayed a "system error, out of service, revert to manual cpr" error message was confirmed during the archive data review and functional testing.The root cause of the system error is related to a communication error that caused a latch-up of the processor board.During the archive data review, system error 132 (internal watchdog timeout) was observed, thus confirming the reported 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 on, thus confirming the reported complaint.Zoll service personnel used the ap vision software to clear the system error.Upon resetting, the platform was re-evaluated through the run_in test using the 95% large resuscitation test fixture (lrtf) with four good known test batteries until discharged without fault or error.Following the service, the autopulse platform passed the final run-in test using the 95% patient large resuscitation test fixture (lrtf) with good known test batteries without fault or error.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 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: 21602023
• Report Number: 3010617000-2025-00200
• Device Sequence Number: 4431212
• Product Code: DRM
• UDI-Device Identifier: 00849111001014
• UDI-Public: 00849111001014
• Combination Product (Y/N): N
• Initial Reporter Country: HR
• 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: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/13/2025

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: 8700-0740-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/19/2025
• Initial Report FDA Received Date: 03/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/06/2017
• 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