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	02/09/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported complaint that the autopulse platform (sn (b)(6)) would not start compressions due to the displayed fault code 16 (timeout moving to take-up position) and user advisory (ua) 23 (compression will exceed 3 revolutions) error messages was confirmed during review of the archive data but not during functional testing.Fault code 16 and ua23 error message were not reproduced during functional testing.A review of the archive data showed fault code 16 and ua23 near the event date; thus, confirming the reported complaint.The autopulse platform passed the initial functional testing without any fault or error.The fault code 16 and ua23 were not reproduced.Unrelated to the reported complaint, the load cell characterization test indicated load cell #1 was defective.Load cell #1 was replaced to remedy the issue.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.Per the battery hangtag - advisory codes description and action, fault code 16 is an indication that there is obstruction between the lifeband and patient, or a twisted lifeband.The recommended actions to take for this type of user advisory are: open lifeband, clear obstruction or twist, pull up completely on the lifeband, ensure that the patient and the band are properly aligned, and press restart.Per autopulse user advisory list guide, user advisory 23 error message is an indication that the driveshaft will need to travel out of the specified range to get to the calculated compression depth.Typically, this error is an indication of an internal component error or a malfunction.The ua23 error message may be cleared when the user presses restart.During service, the autopulse platform passed the run-in test without any fault or error.The autopulse platform passed the final testing without any fault or error.
Event or Problem Description
This occurred during a near-witnessed cpr.The patient was placed on the autopulse platform (sn (b)(6)) correctly.No compressions occurred as the displayed error messages could not be cleared.They were again unable to fix this in the moment so they switched to the lucas device.Upon returning to the station, they tried multiple tests at the station and there were several times it did not work.Fault code 16 (timeout moving to take-up position) and user advisory (ua) 23 (compression will exceed 3 revolutions) error messages were observed.No impact or consequence to the patient reported.

• 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: 24683232
• Report Number: 3010617000-2026-00176
• Device Sequence Number: 21342629
• Product Code: DRM
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/24/2026

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: 8700-0730-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/26/2026
• Initial Report FDA Received Date: 03/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/29/2022
• 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