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	01/20/2026
Type of Reportable Event	Malfunction
Event or Problem Description
During shift check, the customer reported that the autopulse platform (sn (b)(6) displayed user advisory (ua) 07 (discrepancy between load 1 and load 2 too large) error message.No patient involvement.
Additional Manufacturer Narrative
Zoll has received the autopulse platform for investigation.A follow-up report will be submitted when the investigation has been completed.
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) error message was confirmed during functional testing.The root cause of the ua07 was due to a failure of both single point load cells.The platform failed initial functional testing due to the ua07 displayed upon powering up the platform; thus, confirming the reported complaint.Both load cells need to be replaced to remedy the reported complaint.Waiting for customer approval for repair.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: 24345821
• Report Number: 3010617000-2026-00083
• Device Sequence Number: 18522547
• Product Code: DRM
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 03/17/2026

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: 8700-0700-03
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/20/2026
• Supplement Date Received by Manufacturer: 03/06/2026
• Initial Report FDA Received Date: 02/16/2026
• Supplement Report FDA Received Date: 03/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/03/2020
• 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