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	07/28/2025
Type of Reportable Event	Malfunction
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.
Event or Problem Description
The customer reported that the autopulse platform (b)(6) displayed user advisory (ua) 45 (not at "home" position after power-on/restart) error message.The customer followed zoll's instructions to clear the ua45 advisory with no success.The exact time the problem occurred is unknown.However, patient use information was requested, but no additional information was provided.
Additional Manufacturer Narrative
The reported complaint that the autopulse platform (sn (b)(6) displayed user advisory (ua) 45 (not at "home" position after power-on/restart) error message was confirmed based on the review of the archive data, but was not confirmed during functional testing.The root cause of the ua45 advisory message was that the driveshaft was not in the "home" position.However, before sending the platform to zoll for service, the encoder driveshaft had been rotated back to its "home" position, and the ua45 had been cleared.A user advisory is typically a clearable advisory message and is built into the platform to alert the operator that autopulse has detected one of several conditions.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 (ua) 45 will occur.This user advisory will persist until the driveshaft is returned to its "home" position.To clear the ua45, pull up on the lifeband until the chest bands are fully extended (thereby moving the driveshaft back to its "home" position), and then press restart.The archive data review indicated ua45 advisory message around the customer's reported event date, confirming the reported complaint.The autopulse platform passed the initial functional test without any fault or error.The reported ua45 error could not be replicated during subsequent functional tests.Zoll is awaiting customer approval for service repair.

• 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: 22825195
• Report Number: 3010617000-2025-00564
• Device Sequence Number: 4431671
• 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): 11/26/2025

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: 8700-0700-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/28/2025
• Supplement Date Received by Manufacturer: 11/03/2025
• Initial Report FDA Received Date: 08/18/2025
• Supplement Report FDA Received Date: 11/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/18/2021
• 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