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	08/26/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported complaint that the autopulse platform (b)(6) displayed a "system error, out of service, revert to manual cpr" error message was confirmed during archive data review and functional testing.A review of the archive data log file indicated the occurrence of system error 139 (unable to hold compression position).The root cause of the system error was determined to be the drivetrain motor brake gap being too wide and out of specification.As a result, the autopulse stopped functioning due to a system error, as designed.The brake gap issue is most likely attributed to wear and tear.A review of the archive data showed system error 139 (unable to hold compression position), thus, confirming the reported complaint.The autopulse platform failed initial functional testing due to "system error, out of service, revert to manual cpr" upon powering up the device, confirming the reported complaint.The brake gap needs to be adjusted to be within the specification to address the system error.Waiting for customer approval for repair.Historical complaints were reviewed for service information related to the reported complaint, and there were three similar complaints reported for autopulse platform with (b)(6).Ccr 51771, reported on oct 27, 2020, ccr 61582, reported on dec 01, 2021, and ccr 71700, reported on feb 01, 2023.The brake gap was adjusted to specification to remedy the system error 139.
Event or Problem Description
During shift check, the customer reported that upon powering on, the autopulse platform (b)(6) displayed a "system error, out of service, revert to manual cpr" error message and didn't work.The customer restarted the platform, but the issue was not resolved.No patient involvement.

• 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: 20249416
• Report Number: 3010617000-2024-00740
• Device Sequence Number: 7291961
• Product Code: DRM
• UDI-Device Identifier: 00849111065009
• UDI-Public: 00849111065009
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/18/2024

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: 8700-0700-03
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/26/2024
• Initial Report FDA Received Date: 09/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/18/2011
• 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