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	06/02/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported during patient use, the autopulse platform (sn (b)(6) displayed "system error, out of service, revert to manual cpr" error message.The platform powered on and performed compressions for about 30 seconds before the error was displayed.No impact or consequence to the patient.
Additional Manufacturer Narrative
The reported complaint that the autopulse platform (sn (b)(6) displayed "system error, out of service, revert to manual cpr" error message was confirmed based on the review of the archive data and during functional testing.The system error was cleared using apvision3 software, and it was not reproduced during the subsequent 15-minute functional test.Nevertheless, the processor pca was replaced as a preventive precautionary measure, as there may have had some intermittent technical issue that could not be directly identified during the functional testing.Archive data review showed the occurrence of system error - 139 (unable to hold compression position), thus, confirming the reported complaint.The autopulse platform failed initial functional testing due to the "system error, out of service, revert to manual cpr" message displayed upon powering up the device.Therefore, the reported complaint was confirmed.Once the error was cleared using the apvision3 software, the device passed a 15-minute functional test with the large resuscitation testing fixture (lrtf), equivalent to a 250-pound patient.The brake gap was inspected and observed to be within specification.The system error could not be duplicated during testing.However, the processor pca assembly was replaced as a precaution against the system error.The device life expectancy is 5 years.The autopulse platform was manufactured in sept.2009 and is over 15 years old.Following service, the autopulse platform passed the run-in test without any fault or error.The autopulse platform passed the final testing without any 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 autopulse platform 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: 22330568
• Report Number: 3010617000-2024-00419
• Device Sequence Number: 21170842
• Product Code: DRM
• UDI-Device Identifier: 00849111000772
• UDI-Public: 00849111000772
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 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: 8700-0730-01-66
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2025
• Is the Reporter a Health Professional?: Yes
• 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: 09/25/2009
• 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