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	02/27/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported during patient use, the autopulse platform (sn (b)(6)) displayed user advisory (ua) 07 (discrepancy between load 1 and load 2 too large).Patient's status information was requested but the customer did not provide a response.
Additional Manufacturer Narrative
The reported complaint that the autopulse platform (sn (b)(6)) displayed user advisory (ua) 07 (discrepancy between load 1 and load 2 too large) was confirmed during functional testing and review of the archive.The root cause of the ua07 was the failure of single point load cell #2.A review of the archive data showed ua07 error messages; thus, confirming the reported complaint.The autopulse platform failed the initial functional testing due to the displayed ua07 error message at power up, confirming the reported complaint.The load-sensing system of the device detected a weight/load imbalance between the two load cells.Upon conducting the load cell characterization test, the result determined that single point load cell #2 was defective (output reading values were over-reported).To resolve the reported complaint, load cell 2 was replaced.Subsequently the load cell characterization test was performed, and the results indicated that both load cells function within the specification.After servicing, the platform passed the run-in test without issue.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 were no similar complaints reported for 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: 24644873
• Report Number: 3010617000-2026-00173
• Device Sequence Number: 9918918
• Product Code: DRM
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/19/2026

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: 8700-0730-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/27/2026
• Initial Report FDA Received Date: 03/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/16/2023
• 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