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)
Date of Event	12/04/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the autopulse platform (sn (b)(6) displayed user advisory 45 (not at "home" position after power-on/restart).Zoll tech support personnel provided the customer with the instructions for clearing ua45.No further information was provided.It is unknown when the problem occurred.However, patient use information was requested, but no additional information was provided.
Additional Manufacturer Narrative
Zoll has not received the platform for investigation.A follow-up report will be submitted when the product is returned, and the investigation has been completed.
Additional Manufacturer Narrative
The autopulse platform (sn (b)(6)) involved in the reported complaint will not be returned for evaluation because the customer cleared the user advisory (ua) 45 (not at "home" position after power-on/restart) error message using the instructions provided by a zoll representative.The root cause of the ua45 error was due to the driveshaft not being in the "home position".The autopulse platform is functional and has been returned to clinical use.Therefore, the service was not required to be performed by zoll.User advisory is a clearable error message; per the autopulse® resuscitation system model 100 user guide, if the driveshaft is not at its home position when the autopulse is powered on, a user advisory (45) will occur.This user advisory will persist until the driveshaft is returned to its home position.To clear a user advisory (45), pull up on the lifeband until the chest bands are fully extended (thereby moving the driveshaft back to its home position), and then restart.

• 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: 23920710
• Report Number: 3010617000-2025-00898
• Device Sequence Number: 9338391
• Product Code: DRM
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/21/2026

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?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/04/2025
• Supplement Date Received by Manufacturer: 12/30/2025
• Initial Report FDA Received Date: 12/30/2025
• Supplement Report FDA Received Date: 01/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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