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); Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/13/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported complaint that "the autopulse platform (sn (b)(6) repeatedly stopped compressions and then turned off completely" was not confirmed during the archive data review or functional testing.No device malfunction was found during testing at zoll, and the autopulse platform functioned as intended.The autopulse platform passed the initial functional test without fault or error, and the customer's reported complaint was not replicated.The battery connector and all the wiring were inspected, and no issue was found.The autopulse platform was tested with manikin and the lrtf (large resuscitation test fixture) using five different batteries.No error was detectable, and the autopulse platform passed the functional tests with no issues.Following service, the autopulse platform passed all testing criteria.
Event or Problem Description
The customer received a report of an unconscious patient and attempted to resuscitate the patient using the autopulse platform (sn (b)(6).En route, the customer was informed that bystanders had initiated telephone-based cpr.Upon the arrival of the emergency services, the crew found the patient lying in the garden, having been resuscitated for about 7 minutes.The crew took over the resuscitation efforts, diagnosed ventricular fibrillation, and applied the patches.The crew immediately placed the autopulse platform on the stretcher and resuscitated the patient.The initial positioning on the platform was incorrect, as the patient's arms were also strapped in, but the autopulse did not display any error messages and turned off.After correcting the patient's position, the crew turned the autopulse back on and attempted to continue the resuscitation.This time, the device compressed the patient's chest 5-6 times and then turned off completely, without displaying any error messages.This was repeated approximately 5-6 times.Therefore, the crew switched to manual cpr.No consequences or impacts on the patient.Upon later inspecting the device after the call, the customer confirmed that the battery was fully charged and correctly inserted and locked in place, ruling out these potential sources of error.The autopulse platform was then taken out of service.

• 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: 21473118
• Report Number: 3010617000-2025-00157
• Device Sequence Number: 12971827
• Product Code: DRM
• UDI-Device Identifier: 00849111001038
• UDI-Public: 00849111001038
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 02/26/2025

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: 8700-0740-08
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/06/2025
• Initial Report FDA Received Date: 02/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/22/2019
• 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