MAUDE Adverse Event Report: Zoll Circulation, Inc. AutoPulse®Resuscitation System; Cardiac resuscitator, line-powered

Model Number	100
Medical Device Problem Codes	No Display/Image (1183); Noise, Audible (3273)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/28/2026
Type of Reportable Event	Malfunction
Event or Problem Description
During device check, the autopulse platform (sn (b)(6)) lcd failed to display data and generated a clicking sound when the lifeband was connected.The autopulse platform failed to operate.No patient involvement.
Additional Manufacturer Narrative
Zoll has not received the autopulse platform for investigation.A follow-up report will be submitted if and when the product is returned, and the investigation has been completed.

• 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 ; +1(408)419-2347
• MDR Report Key: 50869923
• Report Number: 3010617000-2026-00589
• Device Sequence Number: 13067248
• Product Code: DRM
• UDI-Device Identifier: 00849111000512
• UDI-Public: 00849111000512
• Combination Product (Y/N): N
• Initial Reporter State: ID
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/23/2026

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: 8700-0730-01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/28/2026
• Initial Report FDA Received Date: 09/23/2026
• 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