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

Model Number MODEL 100

Device Problems Use of Device Problem (1670); Unexpected Shutdown (4019)

Patient Problem Insufficient Information (4580)

Event Date 12/12/2022

Event Type  Injury  

Manufacturer Narrative

The reported complaint that "the autopulse platform (sn (b)(4) displayed a "too heavy " message and powered off" was not confirmed based on analysis of the archive data and functional testing.Unable to confirm the customer's reported complaint.There was no physical damage observed on the returned platform during the visual inspection.Archive data review showed multiple occurrences of fault code 16 (timeout moving to take-up position), unrelated to the reported complaint.The autopulse platform failed the initial functional testing and displayed fault code 16, unrelated to the reported complaint.The root cause of the issue was a seized brake gap, due to rust, likely attributed to maintenance.A review of the autopulse platform archive revealed that daily checks were not performed which likely caused the brake gap to be seized.Performing regular daily checks and storing the device in a location with low humidity will prevent the brake gap from seizing.The device checks are required per the user manual to help prevent the gap from seizing.The brake gap was cleaned using ipa (isopropyl alcohol) to unsized to remedy the fault.Subsequently, the autopulse platform passed a run-in test using the 95% large resuscitation test fixture (lrtf) with known-good test batteries for 15 minutes without any issues.During further testing, unrelated to the reported complaint, the autopulse platform failed the load cell characterization test.The root cause was due to the defective load cell module 1, likely attributed to a failed component, or mishandling such as a drop.The defective load cell module 1 needs to be replaced to remedy the fault.Waiting for customer approval for repair.

Event Description

The autopulse platform (sn (b)(4) was used to resuscitate a patient 73 years old female, 180 lbs) in cardiac arrest.The patient was placed on the platform and the device powered on, however, the platform displayed a "too heavy " message and powered off.The patient's status information was requested but the customer did not provide a response.

Event Description

The patient was initially admitted with stemi and the target vessel was lad.The patient received heparin during pci.After a pci and before sso2 therapy, timi flow grade 2 or 3.After pcr prior to initiating ss02, an act was obtained to confirm therapeutic levels of anticoagulation.Another act was taken after 30 minutes of ss02 therapy and additional anticoagulation was administered in an unknown dosage.Therox device was used for 60 minutes.Post-angioplasty angiography of the lad revealed a stent in the proximal portion, while repeat angiography after ss02 treatment showed a patent stent with multiple filling defects in the proximal and midsegments of the lad, indicating intracoronary thrombus.The patient didn't experience any clinical symptoms suggested of an in-stent thrombus.It was a finding during coronary angiography.Post-export thrombectomy and balloon dilation of the previously deployed stent, the site of stent deployment showed no residual stenosis, thrombus, or dissection, and there was timi grade 3 distal flow.The patient was given aspirin and brilinta prior to the interventional procedure and continued on intravenous integrilin post-procedure due to a thrombus in the proximal lad stent area, which improved significantly after manual thrombectomy and repeat stent dilation.In the opinion of the customer, stent thrombosis was potentially related to sso2 therapy.

• 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: 16129427
• MDR Text Key: 307002867
• Report Number: 3010617000-2023-00003
• 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: 04/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2023
• 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: 8700-0730-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/23/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/20/2018
• 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
• Patient Age: 73 YR
• Patient Weight: 82 KG
• Patient Ethnicity: Hispanic