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	07/31/2025
Type of Reportable Event	Malfunction
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.
Event or Problem Description
During shift check, the customer noticed that the autopulse platform (sn (b)(6)) sometimes displays "replace battery" error message.Per the customer, the battery was fully charged and calibrated.The customer replaced the battery, but the issue persisted.No patient involvement.
Additional Manufacturer Narrative
Sections d9 and h4 were updated.The reported complaint that the autopulse platform (sn (b)(6) sometimes displays "replace battery" error message was confirmed in the archive data but was not replicated during functional testing.A review of the archive data showed multiple user advisory 04 (battery charge state too low (replace battery)) on various dates around the reported event date, confirming the reported complaint.During the initial functional testing, the reported "replace battery" error message could not be replicated.Nevertheless, the power distribution board (pdb) will be replaced as a preventive precautionary measure to address intermittent occurrences of user advisory 04 (battery charge state too low (replace battery)), as the pdb may have had some intermittent technical problems that could not be consistently identified during the functional testing.Zoll is awaiting the customer's approval for repair.Historical complaints were reviewed for service information related to the reported complaint, and there was no previous history of complaints reported 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: 22868764
• Report Number: 3010617000-2025-00573
• Device Sequence Number: 7733121
• Product Code: DRM
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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): 10/24/2025

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: 8700-0740-10
• 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: 07/31/2025
• Supplement Date Received by Manufacturer: 10/22/2025
• Initial Report FDA Received Date: 08/21/2025
• Supplement Report FDA Received Date: 10/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/10/2020
• 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