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)
Date of Event	12/04/2025
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, the autopulse platform (sn (b)(6) displayed the user advisory 45 (not at "home" position after power-on/restart) error message.The customer was unable to clear the ua.It is unknown when the problem occurred.However, patient use information was requested but no additional information was provided.
Additional Manufacturer Narrative
The reported complaint of the autopulse platform (sn (b)(6) displayed user advisory (ua) 45 (not at "home" position after power-on/restart) error message, and the user was unable to clear the ua45 error message was confirmed during functional testing and archive review.The root cause of the ua45 error was the driveshaft not being in the "home position".Usually, the ua45 error 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, during further testing, it was found that the encoder driveshaft was difficult to rotate manually.This is usually caused by sharp edges on all 12-hex edges of the armature plate or by burrs on the surface of the clutch rotor, possibly due to wear and tear.The archive data show the presence of a ua45 error message around the customer's reported date, likely related to the drive shaft not being in the home position at power-on, confirming the reported complaint.The autopulse platform failed functional testing due to ua45 being displayed upon powering on, and a sticky clutch was observed, confirming the customer's complaint.The drive shaft was rotated to the home position to address the ua45.The clutch plate was deburred to address the sticky clutch issue.Following service, the autopulse platform passed the run-in test using the 95% patient large resuscitation test fixture (lrtf) with good known test batteries, with no faults or errors.The autopulse platform passed final testing without any faults or errors.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: kimthoa sackrison ; 2000 ringwood ave.; san jose, CA 95131
• MDR Report Key: 23920627
• Report Number: 3010617000-2025-00894
• Device Sequence Number: 9029599
• Product Code: DRM
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/30/2025

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: 8700-0700-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/04/2025
• Initial Report FDA Received Date: 12/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/19/2022
• 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