MAUDE Adverse Event Report: ZOLL CIRCULATION, INC AUTOPULSE®RESUSCITATION SYSTEM; CARDIAC RESUSCITATOR, LINE-POWERED

Model Number	100
Medical Device Problem Codes	Use of Device Problem (1670); Visual Prompts will not Clear (2281)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/23/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer reported complaint that the autopulse platform (sn (b)(6)) displayed a "system error, out of service, revert to manual cpr" error message and didn't start compressions was confirmed during the functional testing.The brake gap was observed to be too wide, possibly due to wear and tear.It was adjusted to be within specification, and the system error was cleared.The archive data review could not be completed because the archive data could not be retrieved/read, due to a defective ir port of the processor board, unrelated to 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.The motor brake gap was observed to be out of specification (0.013").The brake gap was adjusted to the specification (0.008").After that, the system error was cleared using ap vision software.A run-in test was conducted on the device with the 95% patient large resuscitation test fixture (lrtf) with known test batteries until discharged without any fault or error.However, because the archive log could not be accessed to determine what the actual system error was, the processor board will also be replaced to prevent further occurrence of the system error and to remedy the archive issue.Waiting for customer approval for repair.Historical complaints were reviewed for service information related to the reported complaint, and there were no similar complaints reported for autopulse platform with (b)(6).
Event or Problem Description
The customer reported that during shift check, the autopulse platform (sn (b)(6)) displayed a "system error, out of service, revert to manual cpr" error message and didn't start compressions.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: 20553050
• Report Number: 3010617000-2024-00832
• Device Sequence Number: 18391329
• 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): 10/28/2024

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: 10/17/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/30/2024
• Initial Report FDA Received Date: 10/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/03/2014
• 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