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	04/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The autopulse platform (sn (b)(6)) displays user advisory 07 (discrepancy between load 1 and load 2 too large) upon powering up.No patient involvement.
Additional Manufacturer Narrative
Zoll has not received the autopulse platform in complaint for investigation.A follow-up report will be filed if and when the product is returned and investigation has been completed.
Additional Manufacturer Narrative
Sections d9, h3, h4, and h6 codes were updated based on the investigation findings.The reported complaint that the autopulse platform (sn (b)(6) displays user advisory 07 (discrepancy between load 1 and load 2 too large) upon powering up was confirmed in the archive data and during functional testing.The root cause of ua07 was defective load cells, likely due to defective components.A review of the archive data showed multiple instances of user advisory 07 (discrepancy between load 1 and load 2 too large) around the customer's reported event date, confirming the complaint.Functional testing failed because the ua07 advisory message was displayed upon powering up the platform, confirming the complaint.The load-sensing system detected a weight/load imbalance between the two load cells during the power-on self-test.A load cell characterization test indicated that both load cell modules were over-reporting.The defective load cells need to be replaced to resolve the complaint.The customer declined the service repair quote.Therefore, service was not performed, and the autopulse platform will be returned to the customer with the label stating, "not for clinical use".Historical complaints were reviewed for service information related to the reported complaint, and there was no previous history of complaints 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: kim thoa sackrison ; 2000 ringwood ave.; san jose, CA 95131 ; 4084192347
• MDR Report Key: 22029563
• Report Number: 3010617000-2025-00347
• Device Sequence Number: 20955540
• Product Code: DRM
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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): 05/05/2026

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: 8700-0740-14
• 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: 04/21/2025
• Supplement Date Received by Manufacturer: 04/10/2026
• Initial Report FDA Received Date: 05/15/2025
• Supplement Report FDA Received Date: 05/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/08/2021
• 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