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	02/05/2026
Type of Reportable Event	Malfunction
Event or Problem Description
During shift check, the autopulse platform (b)(6) displayed fault 41 (patient temperature sensor failure) upon power-on and did not clear.The customer attempted to clear the fault by replacing the lifeband and checking whether the vents were free of obstructions, but the fault persisted.The platform was placed on the hard surface when the fault occurred.The customer usually keeps the autopulse platform in the lab fixed to the portable zoll stand when not in clinical use.No patient involvement.
Additional Manufacturer Narrative
The customer's complaint that the autopulse platform (b)(6) displayed fault 41 (patient temperature sensor failure) upon power-on was confirmed during the archive data review, but not during the functional testing.Based on the archive, the platform displayed fault 41, confirming the reported complaint.The fault was not replicated throughout the testing at zoll.Nevertheless, the temperature sensor will be replaced as a preventive measure, as it may have had intermittent technical issues that could not be directly identified during functional testing.The archive data indicated the occurrence of fault 41, confirming the reported complaint.The autopulse platform passed the functional testing without error or fault.The fault was not replicated during testing, and the platform functioned as intended.Nevertheless, the temperature sensor will be replaced as a preventive measure, as it may have had intermittent technical issues that could not be directly identified during functional testing.Following service, the autopulse platform passed the run-in and final tests without fault or error.Historical complaints were reviewed for service information related to the reported complaint, and no similar complaint was reported for the autopulse platform with (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 ; 4084192347
• MDR Report Key: 24503383
• Report Number: 3010617000-2026-00108
• Device Sequence Number: 16100447
• Product Code: DRM
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/03/2026

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: 8700-0700-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/05/2026
• Initial Report FDA Received Date: 03/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/04/2016
• 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