MAUDE Adverse Event Report: ZOLL CIRCULATION, INC AUTOPULSE®RESUSCITATION SYSTEM; CARDIAC RESUSCITATOR, LINE-POWERED

Model Number	100
Medical Device Problem Codes	Use of Device Problem (1670); Visual Prompts will not Clear (2281)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/18/2024
Type of Reportable Event	Malfunction
Event or Problem Description
During shift check, the customer reported the autopulse platform (sn (b)(6)) stopped compressions due to an unknown error message.No patient involvement.
Additional Manufacturer Narrative
Zoll has received the autopulse platform for investigation.A follow-up report will be submitted when the investigation has been completed.
Additional Manufacturer Narrative
The reported complaint of the autopulse platform (sn (b)(6)) stopped compressions due to an unknown error message was confirmed during review of the archive data.Based on the archive, the unknown error message reported by the customer is likely to be fault 16 (timeout moving to take-up position) error message.Fault 16 was not reproduced during functional testing, however, the drivetrain motor had corrosion at the brake housing area and the encoder gearbox was rusted due to unknown liquid ingresses, and the brake assembly was seized from corrosion.These issues will contribute to the cause of fault 16 and prevent the platform from performing compressions.The root cause is due to the defective encoder gearbox and drivetrain brake gap assembly.A review of the platform archive was performed, and multiple fault 16 messages were observed on the event date, confirming the customer's complaint.No brake activation was observed when the device was powered on.Fault 16 was not reproduced during functional testing.However, related to the reported complaint, the encoder drive shaft did not rotate smoothly, exhibiting binding and resistance, due to the sticky clutch, caused by unknown liquid ingresses.The drivetrain needs to be replaced to remedy the issue.Also, the encoder gearbox was rusted due to unknown liquid ingresses and the brake assembly was seized due to the corrosion at the drive train motor's brake housing area, which prevented the motor from rotating (initiating compression), contributing to fault 16.Isopropyl alcohol (ipa) was used to clean and remove corrosion at the brake housing area however the issue was not remedied.The encoder gearbox and drivetrain need to be replaced to remedy the complaint.Waiting for customer approval for repair.Historical complaints were reviewed for service information related to the reported complaint and there was no previous history of complaints reported for autopulse platform with sn (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: kimthoa sackrison ; 2000 ringwood ave; san jose, CA 95131
• MDR Report Key: 21635777
• Report Number: 3010617000-2025-00202
• Device Sequence Number: 13139474
• Product Code: DRM
• UDI-Device Identifier: 00849111001014
• UDI-Public: 00849111001014
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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): 04/18/2025

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: 8700-0740-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/19/2025
• Supplement Date Received by Manufacturer: 04/11/2025
• Initial Report FDA Received Date: 03/18/2025
• Supplement Report FDA Received Date: 04/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/01/2021
• 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