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

Model Number LUCAS

Device Problem Mechanical Problem (1384)

Patient Problem Cardiac Arrest (1762)

Event Date 01/06/2021

Event Type  Death  

Manufacturer Narrative

Physio-control contacted the customer to request additional information on the patient.The customer provided physio-control with the available patient information.Physio-control evaluated the customers device and was unable to duplicate the reported issue.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 their device ceased to provide mechanical chest compressions while in use with a patient.Manual cpr was provided after the lucas stopped.The patient is deceased.The issue is patient related.The customer indicated that it is unknown if the device use caused or contributed to the reported death.

Manufacturer Narrative

Physio-control further evaluated the customers device and verified the reported issue.Physio replaced the device's internal communication cable to resolve the reported issue.After completing other unrelated repairs, proper device operation was observed through functional and performance testing.The device was returned to the customer for use.Physio-control further evaluated the removed internal communication cable and determined major damage in multiple areas was the cause of the reported issue.

Event Description

The customer contacted physio-control to report that their device ceased to provide mechanical chest compressions while in use with a patient.Manual cpr was provided after the lucas stopped.The patient is deceased.The issue is patient related.The customer indicated that it is unknown if the device use caused or contributed to the reported death.

• 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; redmond WA 98052
• MDR Report Key: 11279858
• MDR Text Key: 230296208
• Report Number: 0003015876-2021-00266
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00883873904565
• UDI-Public: 00883873904565
• Combination Product (y/n): N
• PMA/PMN Number: K090422
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 07/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 99576-000024
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2021
• Initial Date Manufacturer Received: 01/07/2021
• Initial Date FDA Received: 02/04/2021
• Supplement Dates Manufacturer Received: 07/21/2021
• Supplement Dates FDA Received: 07/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 71 YR
• Patient Weight: 75