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

Model Number LUCAS

Device Problems Electrical /Electronic Property Problem (1198); Unexpected Therapeutic Results (1631)

Patient Problem Cardiac Arrest (1762)

Event Date 12/15/2023

Event Type  Death  

Event Description

A customer contacted stryker to report that their device had stopped compressions during patient's care.If a device malfunctions, the device operating instructions indicate that the user is to remove the device and immediately start manual chest compressions.The patient associated with the reported event did not survive.

Manufacturer Narrative

A stryker field service representative performed an initial evaluation of the customer¿s device and was not able to duplicate the reported issue.However, the stryker field service representative observed that an error had been logged out and found a crease on the communication cable between the protective and control boards.This cable was replaced 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.Stryker contacted the customer to request additional information on the patient.The customer provided stryker with the available patient information.Patient fields in which information is not provided were intentionally left blank.Stryker performed a clinical review regarding the reported issue.And, it was observed that the device use may have contributed to the event.It was considered and user error because when the device stopped to function, the rescuer started manual cpr after about 30 s and this is not according to the instruction for use, manual cpr should be started immediately.

• Brand Name: LUCAS ® 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; SW SE-223 70
• Manufacturer (Section G): JOLIFE AB - 3005445717; scheelevagen 17; ideon science park; lund SE-22 3 70; SW SE-223 70
• Manufacturer Contact: brian blakeslee ; 11811 willows road ne; redmond, WA 98052 ; 4258674000
• MDR Report Key: 18540574
• MDR Text Key: 333193943
• Report Number: 3005445717-2024-00002
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00883873834329
• UDI-Public: 00883873834329
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K173553
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Source Type: User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/09/2024,01/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2024
• 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: 12/18/2023
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/15/2023
• Device Age: 4 YR
• Event Location: Other
• Date Report to Manufacturer: 01/09/2024
• Date Manufacturer Received: 01/09/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/25/2019
• 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
• Patient Outcome(s): Death
• Patient Age: 53 YR
• Patient Sex: Male
• Patient Weight: 82 KG