MAUDE Adverse Event Report: PHYSIO-CONTROL, INC. - 3015876 LUCAS¿ CPR CHEST COMPRESSION SYSTEM; COMPRESSOR, CARDIAC, EXTERNAL / DRM

Model Number LUCAS

Device Problems Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Cardiac Perforation (2513)

Event Date 12/11/2019

Event Type  Injury  

Manufacturer Narrative

Physio-control contacted the customer to request additional information on the patient.The customer provided physio-control with all the available patient information.A clinical review of the event was performed and it can not be excluded that the use of the lucas device may have contributed to the cardiac perforation.Physio-control continues to investigate the reported failure and will submit a supplemental report on this event to the fda as provided by 21 cfr 803.56.

Event Description

The customer contacted physio-control to report that a patient incurred a cpr related laceration/perforation after receiving both manual cpr and cpr by a lucas device.The patient received operative repair and was taken to the icu in critical condition.The patient later expired.

Event Description

The customer contacted physio-control to report that a patient incurred a cpr related laceration/perforation after receiving both manual cpr and cpr by a lucas device.The patient received operative repair and was taken to the icu in critical condition.The patient later expired.

Manufacturer Narrative

Physio-control evaluated the customer's device and found no issues with the device.Proper device operation was observed through functional and performance testing, and the device was returned to the customer for use.This type of injury is common during manual cpr, however the clinical review performed was unable to determine if the laceration/perforation was caused by manual or mechanical cpr.

• Brand Name: LUCAS¿ CPR CHEST COMPRESSION SYSTEM
• Type of Device: COMPRESSOR, CARDIAC, EXTERNAL / DRM
• Manufacturer (Section D): PHYSIO-CONTROL, INC. - 3015876; 11811 willows road ne; ideon science park; redmond WA 98052
• MDR Report Key: 9576217
• MDR Text Key: 174541068
• Report Number: 0003015876-2020-00076
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00883873834329
• UDI-Public: 00883873834329
• Combination Product (y/n): N
• PMA/PMN Number: K173553
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 04/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: LUCAS
• Device Catalogue Number: 99576-000063
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2020
• Date Manufacturer Received: 04/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 57 YR
• Patient Weight: 87