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

Model Number	100
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported complaint that the autopulse platform (sn: (b)(6) malfunctioned was not confirmed in the archive data or during functional testing.The autopulse platform functioned as intended.Reviewing the archive data showed no significant discrepancies or error messages.The autopulse platform passed initial functional testing without any fault or error.A brake gap inspection was performed and verified the brake gap was within the specification.A load cell characterization test confirmed that both load cell modules were functioning within the specifications.Following service, the autopulse platform passed all testing criteria.
Event or Problem Description
Initially, the customer had requested logs from the autopulse platform (sn: (b)(6) to be reviewed by zoll service without reporting any malfunction.Upon follow-up on (b)(6) 2025, the customer provided additional information stating that the autopulse platform (sn: (b)(6) malfunctioned during use on a 72-year-old male patient in cardiac arrest.The reporter described the treatment as prolonged resuscitation, but they didn't know whether the platform had displayed any error messages.The issue did not replicate following the event.Manual cpr was administered when the malfunction occurred.No consequences or impacts on the patient.

• 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: 23577673
• Report Number: 3010617000-2025-00804
• Device Sequence Number: 13076375
• Product Code: DRM
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 11/17/2025

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
• Date Returned to Manufacturer: 10/09/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/30/2025
• Initial Report FDA Received Date: 11/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/19/2021
• 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 Age: 72 YR
• Patient Sex: Male