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

Model Number MODEL 100

Device Problems Use of Device Problem (1670); Visual Prompts will not Clear (2281)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

The customer reported that autopulse platform (sn (b)(6)) displayed an unknown error message.Based on the archive data review, the platform displayed multiple fault code 30 (error communicating with fan controller) and (ua) 04 (battery charge state too low) errors between 09/27/2023 and 10/02/2023.Technical evaluation of the platform revealed extensive corrosion on all circuit boards and connectors as a root cause of the observed errors in the archive.The corrosion damage inside the platform was likely caused by a fluid ingress as a result of user mishandling as the preventative maintenance of the platform was performed in june 2023.Corrosion damage to the circuit boards and connectors likely caused the unresponsive control panel and the fully charged batteries to show as empty.All affected components require a replacement to remedy the issues.During the visual inspection, unrelated to the reported complaint, extended corrosion damage to the aluminum frame (motor mount), and metalized inner surface coating of the autopulse top cover was noted.The damaged parts need to be replaced to address the damage.Also, noted the encoder drive shaft does not rotate smoothly, and exhibits binding and resistance due to a sticky clutch plate, unrelated to the reported complaint.The sticky clutch plate needs to be deburred to address the issue.The impact of a sticky clutch was not severe enough to make the platform non-functional.During initial functional testing, unrelated to the reported complaint, the autopulse platform displayed a fault code 16 error message upon powering on, likely due to corrosive damage to the drivetrain motor.Waiting on the customer's approval for service 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 sn (b)(6).

Event Description

During the device check, the autopulse platform (sn (b)(6)) displayed unknown error messages and the control panel was unresponsive.The platform was tested with multiple fully charged batteries, however, they all showed as empty on the platform.The customer cleaned the battery contacts in the platform without any success.No patient involvement.

• Brand Name: AUTOPULSE® RESUSCITATION MODEL 100
• Type of Device: 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 nguyen ; 2000 ringwood ave; san jose, CA 95131 ; 4084192922
• MDR Report Key: 18009181
• MDR Text Key: 326577406
• Report Number: 3010617000-2023-00937
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111001038
• UDI-Public: 00849111001038
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K112998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MODEL 100
• Device Catalogue Number: 8700-0740-08
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2023
• Date Manufacturer Received: 10/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/13/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1