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	11/18/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported complaint that the autopulse platform (sn (b)(6) displayed user advisory 45 (not at "home" position after power-on/restart) was confirmed in the archive data and during functional testing.When the platform's driveshaft is not in its "home" position, ua45 is triggered.This advisory is typically resolved by pulling up on the lifeband until the band is fully extended, which will return the driveshaft to its "home" position.However, this platform's encoder driveshaft was not rotating smoothly and exhibited binding and resistance.This issue made it difficult for the user to fully pull up the lifeband prior to powering on the device.The lifeband clip insertion slot next to the encoder was damaged.This damage interfered with the driveshaft rotation and is likely the main cause of the ua45 advisory.To resolve the complaint, the encoder gearbox assembly must be replaced.Reviewing the archive data showed multiple user advisory (ua) 45 (not at "home" position after power-on/restart) around the event date, confirming the customer's reported complaint.The platform failed the preliminary functional testing due to a ua45 advisory message displayed upon powering up, confirming the reported complaint.The defective encoder gearbox assembly (with the driveshaft) needs to be replaced to remedy the fault.Zoll is awaiting the customer's approval for service.Historical complaints were reviewed for service information related to the reported complaint, and there were no similar complaints reported for the autopulse platform with sn (b)(6).
Event or Problem Description
During shift check, the autopulse platform (sn (b)(6) displayed user advisory (ua) 45 (not at "home" position after power-on/restart).No patient involvement.

• 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: kim thoa sackrison ; 2000 ringwood ave.; san jose, CA 95131 ; 4084192347
• MDR Report Key: 22443946
• Report Number: 3010617000-2025-00470
• Device Sequence Number: 8028038
• Product Code: DRM
• UDI-Device Identifier: 00849111001014
• UDI-Public: 00849111001014
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/08/2025

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: 06/03/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/19/2025
• Initial Report FDA Received Date: 07/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/08/2021
• 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