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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/13/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported complaint that "the autopulse platform (sn (b)(4)) displayed "system error, out of service, revert to manual cpr " message was confirmed during both archive data review and functional testing.The root cause of the system error was likely due to the drivetrain motor brake assembly air gap was out of specification, likely attributed to an aging device.The drivetrain brake assembly was replaced in (b)(6) 2019 and it was cleaned and adjusted in (b)(6) 2020 for the same issue.Therefore, user mishandling/neglect cannot be ruled out as no documented report was found showing that regular preventative maintenance (pm) was performed since the last service of the device.Performing regular preventive maintenance would prevent the brake gap from seizing and causing the autopulse platform to stop functioning with a system error, per design.The autopulse platform was manufactured in october 2017 and has reach the service life of 5 years.During visual inspection, observed both patient head restraint loop wires were cut, unrelated to the reported complaint.The patient head restraint loop wires could have been cut to free the patient from the platform or the user could have been lifting the platform by holding the head restraints.The cut or damaged head restraint does not render the autopulse platform non-functional.The top cover needs to be replaced to address these damages issue.Further visual inspection, unrelated to the reported complaint, found that the load plate cover defected with a hole that affects the watertight seal, and screws were missing from the platform's cover, likely attributed to mishandling such as a drop.The load plate cover needs to be replaced and new screws needs to be mounted on the cover to address observed issues.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, thus, confirming the customer's reported complaint.The root cause of the system error was likely due to the drivetrain motor brake assembly air gap was out of to the reported complaint, and there was one similar complaint reported for autopspecification.The brake gap could not be adjusted, and the drivetrain motor brake assembly will be replaced to address the reported complaint.Waiting on customer's approval for service repair.Historical complaints were reviewed for service information related ulse platform with serial number (b)(4).(b)(4), reported on (b)(6) 2019, the drivetrain brake assembly was replaced to remedy the "system error, out of service, revert to manual cpr " message.
Event or Problem Description
During shift check, the autopulse platform (sn (b)(4)) displayed "system error, out of service, revert to manual cpr " message.No patient involvement.

• 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 thoa nguyen ; 2000 ringwood ave,; san jose, CA 95131 ; 4084192922
• MDR Report Key: 16158964
• Report Number: 3010617000-2023-00037
• Device Sequence Number: 7005314
• Product Code: DRM
• UDI-Device Identifier: 00849111002530
• UDI-Public: 00849111002530
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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): 01/13/2023

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: 8700-0740-14
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/25/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/20/2022
• Initial Report FDA Received Date: 01/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2007
• 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