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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/29/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zoll has not received the autopulse platform in complaint for investigation.A follow-up report will be filed if and when the product is returned and investigation has been completed.
Event or Problem Description
During shift check, the customer reported that the autopulse platform (sn (b)(6)) displayed an unknown error message and interrupted the compression.No patient involvement.
Additional Manufacturer Narrative
Sections d9 and h4 were updated.The customer reported that the autopulse platform (sn (b)(6) displayed an unknown error message and interrupted the compression.Upon reviewing archive data, it was found that the autopulse platform repeatedly displayed user advisory (ua) 45 (not at "home" position after power-on/restart) when powering up on the reported event date.The ua45 advisory message was replicated during functional testing.The root cause of the ua45 message was that the driveshaft was not in its "home" position.The ua45 message can be easily cleared by pulling up the lifeband until the chest bands are fully extended.This action will move the driveshaft to its "home" position.However, in this case, the encoder driveshaft exhibited binding and resistance, preventing smooth rotation due to a sticky clutch.The autopulse platform failed to provide compression during the preliminary functional testing due to a ua45 advisory message displayed upon powering up, confirming the reported complaint.The driveshaft was stiff and couldn't be manually rotated to its "home" position to clear the ua45 advisory message.The cause was the burred clutch plate, which was deburred and cleaned to remedy the problem.Subsequently, 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 fault or error.Following service, the autopulse platform passed all testing criteria.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 serial number (b)(6).

• 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: kim thoa sackrison ; 2000 ringwood ave.; san jose, CA 95131 ; 4084192347
• MDR Report Key: 22155379
• Report Number: 3010617000-2025-00390
• Device Sequence Number: 20649522
• Product Code: DRM
• UDI-Device Identifier: 00849111001014
• UDI-Public: 00849111001014
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• 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): 06/25/2025

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: 8700-0740-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/13/2025
• Supplement Date Received by Manufacturer: 06/09/2025
• Initial Report FDA Received Date: 06/05/2025
• Supplement Report FDA Received Date: 06/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/03/2024
• 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