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

Model Number MODEL 100

Device Problem Visual Prompts will not Clear (2281)

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

Event Date 01/15/2024

Event Type  malfunction  

Manufacturer Narrative

The reported complaint that the autopulse platform (sn (b)(6)) displayed "system error, out of service, revert to manual cpr" was confirmed during functional testing.The platform's archive data was corrupted and could not be downloaded.The platform and diagnostic service pc were able to communicate momentarily, and apvision3 software confirmed a system error - 136 (internal parameter corrupted).The root cause of the system error was the processor board (pca) failure, likely due to the age of the device.The autopulse platform was manufactured in april 2007 and is almost 17 years old, well beyond its expected service life of 5 years.Upon visual inspection, no apparent physical damage was observed.Further inspection revealed that the clutch plate was very sticky, unrelated to the reported complaint.This is usually caused by sharp edges from all 12-hex edges of the armature plate or due to burrs on the surface of the clutch rotor, likely attributed to wear and tear.The impact of the sticky clutch was not severe enough to make the platform non-functional.Deburring the clutch plate did not resolve the issue.The clutch plate was replaced to remedy the problem.An archive review could not be performed because the data could not be downloaded due to the size of the data being over the limit, and the parameters in backup memory (non-volatile ram) had been corrupted due to the processor board issue.The autopulse platform failed initial functional testing as the platform displayed "system error, out of service, revert to manual cpr" upon powering up, confirming the reported complaint.Technical investigation revealed that the cause of the system error was the processor board failure, which was replaced to remedy the fault.Following service, the autopulse platform was subjected to run-in tests using the 95% large resuscitation test fixture (lrtf) with known good test batteries until discharged without any fault or error.Historical complaints were reviewed for service information related to the reported complaint, and there were no similar complaints reported for the autopulse platform with serial number (b)(6).

Event Description

During shift check, the autopulse platform (sn (b)(6)) displayed "system error, out of service, revert to manual cpr".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 thoa nguyen ; 2000 ringwood ave.; san jose, CA 95131 ; 4084192922
• MDR Report Key: 18647663
• MDR Text Key: 334623531
• Report Number: 3010617000-2024-00110
• Device Sequence Number: 1
• Product Code: DRM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2024
• 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: 8700-0700-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/16/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/27/2007
• 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