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

Model Number MODEL 100

Device Problem Use of Device Problem (1670)

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

Event Date 12/07/2021

Event Type  malfunction  

Event Description

The autopulse platform (s/n (b)(4)) was used to resuscitate a patient in cardiac arrest.During use, the autopulse platform stopped compressions multiple times.As per the customer, the batteries were fully charged, and the autopulse platform did not display any error codes during use.The customer stated that after each stop, the crew reset the autopulse platform by pulling the lifeband back to the neutral position.Additionally, the crew attempted to troubleshoot the issue by turning off the autopulse, removing and changing the battery, and restarting the platform.However, the customer was unable to restart the autopulse and reverted to manual cpr.Ultimately, the ems crew used another automated cpr device to finish the call.No consequences or impact to the patient.

Manufacturer Narrative

The autopulse platform in complaint was returned to zoll on december 28, 2021 for investigation.However, investigation is still in progress.A supplemental report will be filed when investigation has been completed.

Manufacturer Narrative

The reported complaint that "the autopulse platform (s/n (b)(6) stopped compressions multiple times" was confirmed in both the archive data and during functional testing.The customer stated that the autopulse platform did not display any error codes during use; however, a review of the archive data showed the autopulse platform had stopped compressions multiple times due to user advisory (ua) 17 (max motor on time exceeded during active operation) during active operation around the customer's reported event date.The root cause of the issue was the defective drivetrain motor due to a defective component.During visual inspection of the returned platform, a crack was observed at the lower corner on the patient's left-hand side of the top cover.The observed physical damage is unrelated to the reported complaint, and the root cause appeared to be the characteristic of harsh impacts due to user mishandling.The top cover was replaced to address the issue.The autopulse platform passed the initial functional test without any fault or error.However, during further run-in stress testing, the autopulse platform repeatedly stopped compressions due to ua17 advisory messages; thus, confirming the customer's reported complaint.Troubleshooting the problem revealed that the ua17 was caused when the autopulse did not reach the target compression depth within the required time.The root cause of the intermittent occurrences of the ua17 advisory message was found to be the defective drivetrain motor, and it was replaced to remedy the fault.Following service, a brake gap inspection was performed and verified the brake gap was within specification.The autopulse was subjected to a final run-in test using the 95% patient large resuscitation test fixture (lrtf) with known-good test batteries until fully discharged without any fault or error.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 serial number (b)(6).

• Brand Name: AUTOPULSE® PLATFORM RESUSCITATION
• 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: 13102476
• MDR Text Key: 283587446
• Report Number: 3010617000-2021-01223
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111000512
• UDI-Public: 00849111000512
• 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,Followup
• Report Date: 01/14/2022

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
• 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: 12/28/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/07/2021
• Initial Date FDA Received: 12/28/2021
• Supplement Dates Manufacturer Received: 01/04/2022
• Supplement Dates FDA Received: 01/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/11/2019
• 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