MAUDE Adverse Event Report: ZOLL CIRCULATION 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	09/28/2023
Type of Reportable Event	Malfunction
Event or Problem Description
During the preventative maintenance (pm) on (b)(6) 2023, the returned autopulse platform sn (b)(6) failed functional testing due to the "system error, out of service, revert to manual cpr" message displayed upon powering up.No patient involvement.
Additional Manufacturer Narrative
During preventive maintenance, the autopulse platform (sn 41447) displayed a "system error, out of service, revert to manual cpr" error message upon powering on.The root cause for the observed issue was due to a communication error between the drivetrain motor and the processor board, as a result of normal wear and tear.The autopulse platform was manufactured in november 2015 and is almost 8 years old, well beyond the expected service life of 5 years.The platform was connected to the autopulse vision software, and the error message was cleared.During further testing, the platform failed with the fault code 08 (motor controller fault detected) due to a failed motor controller board, which is likely attributed to normal wear and tear.The failed motor controller board was replaced to remedy the fault.The brake gap inspection was performed and verified the brake gap was within the specification.During visual inspection found the encoder drive shaft does not rotate smoothly, and exhibits binding and resistance due to a sticky clutch plate.This type of drive shaft issue is characteristic of normal wear and tear.Deburring of the clutch plate was performed to remedy the encoder driveshaft issue.The impact of the sticky clutch was not severe enough to make the platform non-functional.Archive data review showed the occurrence of system error - 139 (unable to hold compression position) error message.Upon further review of the archive data, noticed a fault code 16 (timeout moving to take-up position) and user advisory (ua) 17 (max motor on time exceeded during active operation) error message, that were likely related to the failed motor controller board.Following service, the autopulse platform passed the run-in test using the 95% patient large resuscitation test fixture (lrtf) with good known test batteries until discharged 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 the autopulse platform with sn (b)(6).
Additional Manufacturer Narrative
**udi related data quality updates only**.

• Brand Name: AUTOPULSE® RESUSCITATION SYSTEM
• Common Device Name: CARDIAC RESUSCITATOR, LINE-POWERED
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• Manufacturer (Section G): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• Manufacturer Contact: kim nguyen ; 2000 ringwood ave; san jose, CA 95131 ; 4084192922
• MDR Report Key: 18000910
• Report Number: 3010617000-2023-00910
• Device Sequence Number: 15363016
• Product Code: DRM
• UDI-Device Identifier: 00849111001076
• UDI-Public: 00849111001076
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K112998
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/24/2024

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: 8700-0740-16
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/28/2023
• Supplement Date Received by Manufacturer: 07/15/2024
• Initial Report FDA Received Date: 10/25/2023
• Supplement Report FDA Received Date: 07/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/06/2015
• 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