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	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer's complaint that the autopulse platform (sn (b)(6)) displayed a "system error, out of service, revert to manual cpr" message was confirmed during the functional testing and the archive data review.The root cause of the system error was the drivetrain motor brake gap being wide (out of the specification).This caused the autopulse to stop functioning with a system error, per design.The archive data indicated system error 139 (unable to hold compression position), confirming the reported complaint.The autopulse platform failed the functional testing due to a "system error, out of service, revert to manual cpr" message displayed upon powering up, confirming the reported complaint.The investigation revealed that the root cause of the system error was the wide drivetrain motor brake gap (out of specification).The system error was reset using the ap vision software, and the brake gap needs to be adjusted within the specifications to address the reported complaint.Zoll is awaiting customer approval for service repair.Historical complaints were reviewed for service information related to the reported complaint, and there was no previous history of complaints reported for the autopulse platform with sn (b)(6).
Event or Problem Description
The distributor reported that the autopulse platform (sn (b)(6)) displayed a "system error, out of service, revert to manual cpr" message upon powering on.No further information was provided.It is unknown when the problem occurred.However, patient use information was requested but no additional information was provided.

• 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 ; 4084192347
• MDR Report Key: 20930036
• Report Number: 3010617000-2024-00977
• Device Sequence Number: 8320479
• Product Code: DRM
• UDI-Device Identifier: 00849111002516
• UDI-Public: 00849111002516
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• 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,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/13/2024

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: 8700-0740-04
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/21/2024
• Initial Report FDA Received Date: 12/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/31/2010
• 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