MAUDE Adverse Event Report: ZOLL CIRCULATION, INC AUTOPULSE®RESUSCITATION SYSTEM; CARDIAC RESUSCITATOR, LINE-POWERED

Model Number	100
Medical Device Problem Codes	Use of Device Problem (1670); Visual Prompts will not Clear (2281)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/03/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zoll has not received the autopulse platform in the complaint for investigation.A supplemental report will be filed if and when the product is returned and investigation has been completed.
Event or Problem Description
The customer reported the autopulse platform (sn (b)(6)) displayed user advisory (ua) 45 (not at "home" position after power-on/restart) message that could not be cleared.The drive shaft is hard to turn.This was noticed during shift check.No patient involvement.
Additional Manufacturer Narrative
The customer reported complaint that the autopulse platform (sn (b)(6) displayed user advisory (ua) 45 (not at "home" position after power-on/restart) message and the driveshaft was hard to turn was confirmed during archive data review and functional testing.The root cause for the ua45 error was due to the driveshaft not being at "home position." usually, the 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, in this case, it was observed that the encoder driveshaft was difficult to rotate due to the heavily sticky clutch plate, likely caused by sharp edges from all 12-hex edges of the armature plate, or due to burrs on the clutch rotor's surface, likely attributed to normal wear and tear.This would likely cause the user difficulty pulling up the lifeband completely.During visual inspection, a sticky clutch plate was observed, related to the reported complaint.A review of the archive data showed ua45: thus, confirming the reported complaint.The autopulse platform failed initial functional testing due to the displayed ua45 upon powering up the platform; thus, confirming the reported complaint.The admin menu was accessed to manually rotate the encoder driveshaft to the home position.The clutch plate was deburred to remedy the reported complaints of ua45 and difficulty in turning the driveshaft.Following the service, the autopulse platform passed the run-in and final tests without any faults or errors.Historical complaints were reviewed for service information related to the reported complaint, and there were no similar complaints reported for autopulse platform with serial number sn (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: 23885576
• Report Number: 3010617000-2025-00888
• Device Sequence Number: 9605389
• Product Code: DRM
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 02/27/2026

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/03/2025
• Supplement Date Received by Manufacturer: 02/13/2026
• Initial Report FDA Received Date: 12/23/2025
• Supplement Report FDA Received Date: 02/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/27/2022
• 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