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)
Type of Reportable Event	Malfunction
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 archive data review and functional testing.The root cause of the system error was the drivetrain motor brake gap being too wide, out of specification.As a result, the autopulse stopped functioning with a system error, as designed.The brake gap issue is most likely attributed to wear and tear.The autopulse platform was manufactured in february 2009 and is almost 15 years old, well beyond its expected service life of 5 years.Visual inspection revealed that the top cover was cracked, and the front enclosure was damaged with a broken screw holder.These observed physical damages were unrelated to the reported complaint and are attributed to user mishandling.The top cover and front enclosure were last replaced during servicing at zoll in december 2021.The damaged covers will be replaced to address the observed issues.Reviewing the archive data showed a system error, 139 (unable to hold compression position), confirming the customer's reported complaint.Further review of the archive data showed user advisory ua17 (max motor on time exceeded during active operation), unrelated to 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.Investigation revealed that the drivetrain motor brake gap was too wide, out of specification.This was determined to be the root cause of both the system error and the ua17 advisory message, which occurred prior to the system error.The brake gap was adjusted within the specification to address the issue.The autopulse platform passed all subsequent functional tests without any fault or error.Zoll is awaiting the customer's approval for repair.Historical complaints were reviewed for service information related to the reported complaint, and no similar complaints were reported for the autopulse platform with serial number (b)(6).
Event or Problem Description
During shift check, the autopulse platform sn (b)(6) displayed "system error, out of service, revert to manual cpr".No patient involvement.
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 thoa nguyen ; 2000 ringwood ave.; san jose, CA 95131 ; 4084192922
• MDR Report Key: 18414804
• Report Number: 3010617000-2023-01086
• Device Sequence Number: 2691017
• Product Code: DRM
• UDI-Device Identifier: 00849111000116
• UDI-Public: 00849111000116
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,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: 8700-0700-02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 07/22/2024
• Initial Report FDA Received Date: 12/28/2023
• Supplement Report FDA Received Date: 07/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/27/2009
• 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