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	Insufficient Information (4580)
Date of Event	08/20/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complaint that the autopulse platform (sn (b)(6) stopped after performing one compression was confirmed through archive data and functional testing.The archive data showed that the autopulse platform displayed user advisory 12 (lifeband not present) messages around the reported event date.If a user advisory is not cleared, the autopulse platform powers off as designed.The ua12 advisory message was replicated during functional testing.The root cause of the ua12 advisory was a defective and severely worn belt clip retainer, likely due to the device's age.The device's life expectancy is 5 years.This autopulse platform was manufactured in may 2015 and is over 9 years old.Initial functional testing failed due to the ua12 advisory message displayed upon powering up the platform, as confirmed by the archive data; thus, confirming the reported complaint.Troubleshooting revealed that the belt clip retainer was damaged and severely worn, triggering the ua12 advisory message.Replacing the belt clip retainer is necessary to remedy the fault.Zoll is awaiting the customer's approval for repair.Historical complaints were reviewed for service information related to the reported complaint, and no similar complaints were reported for the autopulse platform with sn (b)(6).
Event or Problem Description
During patient use, the autopulse platform (sn (b)(6) performed chest compressions only once, but then it stopped working.Per the paramedics, they did not check the display panel at this time, and it is unclear if an error message was displayed.The paramedics pressed the start button, but the platform didn't restart chest compressions.The paramedics performed manual cpr and transported the patient.The patient's outcome and any other information after transportation were not provided.

• 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: 20247600
• Report Number: 3010617000-2024-00726
• Device Sequence Number: 17967185
• Product Code: DRM
• UDI-Device Identifier: 00849111065009
• UDI-Public: 00849111065009
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 09/18/2024

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: 8700-0700-03
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/22/2024
• Initial Report FDA Received Date: 09/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/18/2015
• 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