MAUDE Adverse Event Report: JOLIFE AB - 3005445717 LUCAS 2 CPR CHEST COMPRESSION SYSTEM; COMPRESSOR, CARDIAC, EXTERNAL

Model Number LUCAS

Device Problem Electrical /Electronic Property Problem (1198)

Patient Problems Death (1802); No Consequences Or Impact To Patient (2199)

Event Date 11/01/2019

Event Type  Death  

Event Description

The customer contacted physio-control to report that their device blocked during patient use.The users tried to restart the device, but it did not resolve the issue.Subsequently, manual cpr was provided, but it was reported that the reported issue delayed the treatment of the patient.The patient passed away a few days after the event at the intensive care unit.

Manufacturer Narrative

B1 of the initial submission indicated adverse event and product problem.B1 of the initial submission should indicate product problem.B2 of the initial submission indicated death.B2 of the initial submission should indicate blank.F10 of the initial submission indicated the patient code is death.F10 of the initial submission should indicate the patient code is no consequences or impact to patient.H1 of the initial submission indicated the type of reportable event is death.H1 of the initial submission should indicate the type of reportable event is malfunction.A clinical review was performed and it was determined that a use error occurred due to the customer delay in providing manual cpr.This error likely caused the adverse event.The reported malfunction does not inhibit the customer from providing manual cpr immediately in conjunction with the instructions for use.Manual cpr is equivalent to lucas compressions and therefore the lucas device report of blocking (stopping) twice during heart compressions did not contribute to the patient outcome.Physio-control evaluated the customers device and was unable to duplicate the reported issue.Proper device operation was observed through functional and performance testing.The device was returned to the customer for use.

Event Description

The customer contacted physio-control to report that their device blocked during patient use.The users tried to restart the device, but it did not resolve the issue.Subsequently, manual cpr was provided, but it was reported that the reported issue delayed the treatment of the patient.The patient passed away a few days after the event at the intensive care unit.

• Brand Name: LUCAS 2 CPR CHEST COMPRESSION SYSTEM
• Type of Device: COMPRESSOR, CARDIAC, EXTERNAL
• Manufacturer (Section D): JOLIFE AB - 3005445717; scheelevagen 17; ideon science park; lund SE-22 3 70; SE SE-223 70
• MDR Report Key: 9539323
• MDR Text Key: 173354062
• Report Number: 0003015876-2020-00009
• Device Sequence Number: 1
• Product Code: DRM
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Source Type: foreign
• Type of Report: Initial,Followup
• Report Date: 01/02/2020,06/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2020
• 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: 99576-000025
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2019
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/02/2020
• Distributor Facility Aware Date: 12/04/2019
• Device Age: 10 YR
• Event Location: Ambulatory Surgical Facility
• Date Report to Manufacturer: 12/04/2019
• Date Manufacturer Received: 05/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 46 YR
• Patient Weight: 60