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 Type  malfunction  

Manufacturer Narrative

The reported complaint that the autopulse platform (sn (b)(6)) displayed user advisory (ua) 07 (discrepancy between load 1 and load 2 too large) was confirmed during both archive data review and functional testing.The root cause of the ua07 was the failed load cell #1.The broken covers and load cell failure were likely attributed to mishandling, such as a drop.Visual inspection showed that the front enclosure, top cover, load plate cover, and bottom enclosure were all damaged, unrelated to the reported complaint.Based on the photos provided by the zoll service team, all the covers had multiple cracks and were chipped/broken at various locations.Also, the load plate cover was damaged with cuts, affecting the watertight seal.These observed physical damages appeared as characteristic of harsh impacts due to user mishandling.All the damaged parts will be replaced to address the observed issues.A review of the archive data showed multiple user advisory (ua) 07 (discrepancy between load 1 and load 2 too large) around the customer's reported complaint date, confirming the reported complaint.Functional testing failed due to the ua07 advisory message displayed upon powering up the platform, confirming the reported complaint.A load cell characterization test confirmed that the root cause of the ua07 was the failed load cell #1, which was replaced.Subsequently, the autopulse platform passed a functional test using lrtf (large resuscitation test fixture) with known-good batteries for 5 minutes with no problem.Further inspection revealed that the clutch plate was sticky, unrelated to the reported complaint.This is usually caused by sharp edges of the armature plate, or due to burrs on the surface of the clutch rotor.The impact of the sticky clutch was not severe enough to make the platform non-functional.The clutch plate will be deburred to remedy the problem.Upon service completion, the platform will be subjected to final functional testing to ensure the device will pass all testing criteria.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

The autopulse platform (sn (b)(6)) was attempted to be used to resuscitate a patient in cardiac arrest.However, upon powering up, the autopulse platform displayed user advisory (ua) 07 (discrepancy between load 1 and load 2 too large).The customer was unable to clear the ua07 advisory.The patient's status information was requested, but the customer did not provide a response.

• 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: 18665073
• MDR Text Key: 334844538
• Report Number: 3010617000-2024-00122
• 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: 02/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2024
• 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: 8700-0730-01
• 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: 01/17/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/30/2020
• 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