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	06/29/2025
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
During shift check, the customer reported that the autopulse platform (sn (b)(6)) displayed user advisory (ua) 02 (compression tracking error) error message after the first compression.No patient involvement.
Additional Manufacturer Narrative
The customer reported complaint that the autopulse platform (b)(6) displayed user advisory (ua) 02 (compression tracking error) error message after the first compression was confirmed during review of the archive data and functional testing.The root cause was due to a failure of both single point load cells.The archive data review showed multiple ua02 error messages on the event date, thus confirming the reported complaint.The autopulse platform failed the initial functional testing due to the displayed ua02 error message, thus confirming the reported complaint.As the drive shaft rotates and tightens the lifeband, the load sensors did not see the expected increase in load.The load cell characterization test indicated both single point load cells were defective.Both load cells were replaced to remedy the reported complaint.Subsequently, the platform was re-evaluated through the run_in test using the 95% patient large resuscitation test fixture (lrtf) with good known test batteries until discharged without any fault or error.Following service, the autopulse platform passed the final testing without any fault or error.Historical complaints were reviewed for service information related to the reported complaint, and there was no previous history of 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: 22571524
• Report Number: 3010617000-2025-00486
• Device Sequence Number: 11767739
• Product Code: DRM
• Combination Product (Y/N): N
• Initial Reporter Country: VM
• 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): 01/21/2026

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: 8700-0740-01
• 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: 06/30/2025
• Supplement Date Received by Manufacturer: 01/08/2026
• Initial Report FDA Received Date: 07/22/2025
• Supplement Report FDA Received Date: 01/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/02/2023
• 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