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)
Type of Reportable Event	Malfunction
Event or Problem Description
During the shift check, the autopulse platform (sn (b)(6)) displayed a user advisory (ua) 45 (not at "home" position after power-on/restart) message.No further information was provided.No patient involvement.
Additional Manufacturer Narrative
The reported complaint that the autopulse platform (sn (b)(6)) displayed a user advisory (ua) 45 (not at "home" position after power-on/restart) error message was confirmed during functional testing and based on the review of the archive data.The root cause of the reported complaint was a failure of the integrated encoder gearbox, likely attributed to a failed component.The archive data review indicated several ua45 around the reported event date, thus confirming the customer's reported complaint.The autopulse platform failed functional testing as a ua45 displayed upon powering on, thus confirming the customer's reported complaint.The failed integrated encoder gearbox needs to be replaced to address the customer's reported complaint.Zoll is awaiting customer approval for service repair.Historical complaints were reviewed for service information related to the reported complaint, and there was no previous history of complaints reported for the autopulse platform with sn (b)(6).B3, the date of the event is unknown.

• 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 ; 4084192347
• MDR Report Key: 23034176
• Report Number: 3010617000-2025-00614
• Device Sequence Number: 9702040
• Product Code: DRM
• UDI-Device Identifier: 00849111001076
• UDI-Public: 00849111001076
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/11/2025

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: 8700-0740-16
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/19/2025
• Initial Report FDA Received Date: 09/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/16/2021
• 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