MAUDE Adverse Event Report: ZOLL CIRCULATION AUTOPULSE® RESUSCITATION MODEL 100; CARDIAC CHEST COMPRESSOR

Model Number	MODEL 100
Medical Device Problem Code	Failure to Power Up (1476)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/23/2022
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, the autopulse platform sn (b)(4) was found to be not functioning.No additional information was provided.It is unknown where the problem occurred.However, patient use information was requested but no additional information was provided.
Additional Manufacturer Narrative
The reported complaint of he autopulse platform sn (b)(4) was found to be not functioning was confirmed during functional testing as the platform could not power on.The root cause of the observed issue was a defective processor board, likely due to the aging of the device.The autopulse platform was manufactured in january 2008, and it is more than 14 years old, well beyond its expected service life of 5 years.No physical damage was observed on the returned autopulse platform.In addition, unrelated to the reported complaint, the screws in the battery compartment were missing.The observed issue is likely attributed to wear and tear.The screws need to be replaced to remedy the issue.Also, it was noted that the power distribution board (pdb) revision level was below 6 and needs to be updated, attributed to the age of the platform.Initial functional testing could not be performed due to the platform not powering on, thus confirming the reported complaint.To remedy the issue, the processor board needs to be replaced.During further platform testing, unrelated to the reported complaint, the load cell amp board and load cell module 1 were observed defective, likely due to the aging of the device.There were no records of the preventive maintenance performed on the platform since 2008.The load cell amp board and load cell module 1 need to be replaced to address the issue.The brake gap inspection was performed and verified the brake gap was within the specification.Unable to download archive data due to the defective processor board.Waiting for the customer's approval for service.Historical complaints were reviewed for service information related to the reported complaint and there was no previous history of complaints reported for autopulse platform with sn (b)(4).

• Brand Name: AUTOPULSE® RESUSCITATION MODEL 100
• Common Device Name: CARDIAC CHEST COMPRESSOR
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• Manufacturer (Section G): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• Manufacturer Contact: kim thoa nguyen ; 2000 ringwood ave,; san jose, CA 95131 ; 4084192922
• MDR Report Key: 15443011
• Report Number: 3010617000-2022-01624
• Device Sequence Number: 5581941
• Product Code: DRM
• UDI-Device Identifier: 00849111000154
• UDI-Public: 00849111000154
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 09/16/2022

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: MODEL 100
• Device Catalogue Number: 8700-0700-11
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/01/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/23/2022
• Initial Report FDA Received Date: 09/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/01/2008
• 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