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)
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the autopulse platform (b)(6) displayed user advisory 20 (position out of range).It is unknown when the problem occurred.However, patient use information was requested, but no additional information was provided.
Additional Manufacturer Narrative
The reported complaint that the autopulse platform (b)(6) displayed user advisory 20 (position out of range) was confirmed during both archive data review and functional testing.The root cause of the ua20 advisory message was that the driveshaft was not in its "home" position, most likely attributed to unintended user error.The archive data review indicated multiple ua20 advisory messages around the customer's reported complaint date, confirming the reported complaint.User advisory is normally a clearable error message designed into the platform to alert the operator that autopulse has detected one of several conditions.User advisory (ua) 20 occurs due to the encoder driveshaft not being within the normally acceptable range of positions.Typically, if the user advisory (ua) 45 (driveshaft not at "home" position after power-on/restart) is not resolved properly, it leads to ua20 because the driveshaft is not restored at its "home" position.To clear ua20, return the driveshaft to its "home" position using the platform's administrative menu.During functional testing, the autopulse platform displayed the ua20 advisory message upon powering up, confirming the reported complaint.The platform's driveshaft was rotated to its "home" position to address the fault.Subsequently, the autopulse platform was intensively tested, and no errors were displayed.Following service, the autopulse platform passed all testing criteria.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: 24215865
• Report Number: 3010617000-2026-00050
• Device Sequence Number: 8326395
• Product Code: DRM
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 01/29/2026

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: 8700-0740-08
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/08/2026
• Initial Report FDA Received Date: 01/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/29/2024
• 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