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	02/20/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that after the autopulse platform (sn 37542) was cleaned following the call and a new lifeband was installed to return the device to service, the platform displayed user advisory 12 (lifeband not present).During troubleshooting, the lifeband and the battery were removed and reinstalled multiple times; however, the ua12 message continued to appear.There was no patient involvement.
Additional Manufacturer Narrative
The device associated with this complaint has been received, however, the investigation is pending.A follow-up report will be filed when the investigation has been completed.
Additional Manufacturer Narrative
The reported complaint of the autopulse platform (sn (b)(6) displayed the user advisory (ua) 12 (lifeband not present) error message was confirmed during archive review but not during functional testing.The customer's reported complaint was not reproduced.The autopulse platform functioned as intended.The reported ua12 message might be due to the lifeband not being fully inserted and locked when the platform is powered on, and likely attributed to user error.A review of the archive data showed a ua12 advisory message on the reported event date, confirming the reported complaint.The customer's reported ua12 error was not reproduced during the functional testing.The lifeband clip detect switch inspection shows that the switch lever was able to close and is in a parallel position.The platform was verified using a standard belt test clip aid.The platform was tested and operated as intended without a ua12 error message.User advisory is normally a clearable error message and is designed into the autopulse platform to alert the operator that autopulse has detected one of several conditions.User advisory is normally a clearable error message.Per the battery hangtag - advisory codes description and action, user advisory 12 is an indication that the autopulse has detected that the lifeband is not properly installed.The recommended actions to take for this type of user advisory are: ensure that the band clip (underneath the device) is properly seated in the drive shaft can freely rotate after insertion.Following service, the autopulse platform underwent the run-in test using the 95% patient large resuscitation test fixture (lrtf) with the known-good test battery, without any faults or errors.The autopulse platform passed final testing without any faults or errors.

• 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: 24634862
• Report Number: 3010617000-2026-00149
• Device Sequence Number: 8698253
• Product Code: DRM
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 04/15/2025

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: 8700-0730-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/20/2026
• Supplement Date Received by Manufacturer: 03/20/2026
• Initial Report FDA Received Date: 03/18/2026
• Supplement Report FDA Received Date: 04/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/23/2022
• 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