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)
Type of Reportable Event	Malfunction
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 of 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 system error was an internal communication error that caused a latch-up of the processor board.The archive data indicated system error - 132 (internal watchdog timeout), 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 to clear the system error.Upon resetting, the platform was re-evaluated through the run-in test with good known test batteries.Waiting for customer approval for repair.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).B3, the date of the event is unknown.

• 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: 22333451
• Report Number: 3010617000-2025-00418
• Device Sequence Number: 8993829
• Product Code: DRM
• UDI-Device Identifier: 00849111001014
• UDI-Public: 00849111001014
• Combination Product (Y/N): N
• Initial Reporter Country: LG
• 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): 06/25/2025

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: 06/02/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/02/2025
• Initial Report FDA Received Date: 06/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/31/2012
• 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