MAUDE Adverse Event Report: JOLIFE AB - 3005445717 LUCAS 3 CPR CHEST COMPRESSION SYSTEM; COMPRESSOR, CARDIAC, EXTERNAL

Model Number	LUCAS 3
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/23/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Stryker contacted the customer to request additional information on the patient.Stryker requests patient information necessary for regulatory compliance, strictly adhering to hipaa's privacy rule.No response has been received from the customer.Stryker evaluated the customer's device and observed that the device alarmed and paused.After replacing the compression module, proper device operation was observed through functional and performance testing.The device was subsequently returned to the customer for use.
Event or Problem Description
A customer contacted stryker to report a non-critical issue with their device.Upon inspection, it was observed that the device alarmed and paused.In this state, a delay in cardiopulmonary resuscitation may occur.If a device malfunctions, the device operating instructions indicate that the user is to remove the device and immediately start manual chest compressions.There were no reports of harm to the patient as a result of the reported event.

• Brand Name: LUCAS 3 CPR CHEST COMPRESSION SYSTEM
• Common Device Name: 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: 24662836
• Report Number: 3005445717-2026-00097
• Device Sequence Number: 15775307
• Product Code: DRM
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K173553
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/23/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: LUCAS 3
• Device Catalogue Number: 99576-000063
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/25/2026
• Initial Report FDA Received Date: 03/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/27/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown