MAUDE Adverse Event Report: ZOLL CIRCULATION AUTOPULSE RESUSCITATION MODEL 100; CARDIAC CHEST COMPRESSOR

Model Number	MODEL 100
Medical Device Problem Code	Visual Prompts will not Clear (2281)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/08/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Customer reported that the autopulse platform (serial #(b)(6)) displayed "system error, out of service, revert to manual cpr " message.It is unknown where the problem occurred.However, patient use information was requested, but no additional information was provided.
Additional Manufacturer Narrative
The reported complaint that the autopulse platform (sn (b)(6)) displayed "system error, out of service, revert to manual cpr" was confirmed during the functional testing.The root cause of the reported system error was the failed processor board (pca), likely attributed to the aging of the device.The autopulse platform was manufactured in january 2012 and is over 11 years old, past its expected service life of 5 years.No physical damage was observed on the returned autopulse platform.The archive data could not be downloaded to review, likely attributed to the failed processor board.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 customer complaint.To remedy the error message, the failed processor board was replaced.Also, unrelated to reported complaint, further functional testing revealed that the brake gap was out-of-specification (too wide), the brake is open and closed continuously when the autopulse platform was powered on.To remedy this brake gap issue, the brake was cleaned and adjusted.Following service, the autopulse platform was subjected to a run-in test using the 95% large resuscitation test fixture (lrtf) with known good test batteries until discharged without any fault or error.Following service, another brake gap inspection was performed and verified the brake gap was within the specification.The autopulse platform was subjected to a final run-in test using the 95% large resuscitation test fixture (lrtf) with known good test batteries until discharged without any fault or error.Historical complaints were reviewed for service information related to the reported complaint, and there was no previous history of complaint reported for the autopulse platform with serial number (b)(4).

• Brand Name: AUTOPULSE RESUSCITATION MODEL 100
• Common Device Name: CARDIAC CHEST COMPRESSOR
• 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
• MDR Report Key: 17011477
• Report Number: 3010617000-2023-00470
• Device Sequence Number: 20565136
• Product Code: DRM
• UDI-Device Identifier: 00849111001052
• UDI-Public: 00849111001052
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 05/26/2023

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: MODEL 100
• Device Catalogue Number: 8700-0740-02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/08/2023
• Initial Report FDA Received Date: 05/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/01/2012
• 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