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)
Type of Reportable Event	Malfunction
Event or Problem Description
While moving the patient from the ambulance to the hospital bay, hospital staff pulled up the lifeband (lot#: unknown), which remained connected to the autopulse platform (sn: (b)(6).This action caused the lifeband clip to break off inside the drive shaft.According to the vehicle crew, the device was not performing chest compressions when this issue occurred.After the patient was transferred, the hospital staff switched to manual cpr.No consequences or impact to the patient.The issue was identified immediately after the transfer of the patient was completed, during the process of restoring the device's operational readiness.As a result of the lifeband clip break, the new lifeband could not be installed on the platform.
Additional Manufacturer Narrative
The customer reported a complaint that the autopulse platform (sn: (b)(6) can no longer accept a lifeband was confirmed during the visual inspection and functional testing.The root cause of the reported issue was due to a small piece of the broken lifeband band clip being noted in the drive shaft slot as a result of user mishandling.The functional testing of the autopulse platform could not be performed due to the broken clip inside the drive shaft slot.The broken lifeband band clip was removed to address the reported complaint.After removing the broken lifeband band clip, the autopulse platform was subjected to a run-in test using lrtf (large resuscitation test fixture), and the platform functioned as intended.Awaiting the customer's approval for 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 serial number: (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: 22910770
• Report Number: 3010617000-2025-00590
• Device Sequence Number: 9110749
• 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): 08/28/2025

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: 08/01/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/01/2025
• Initial Report FDA Received Date: 08/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/15/2024
• 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