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

Model Number	LUCAS 2
Medical Device Problem Codes	Electrical /Electronic Property Problem (1198); Key or Button Unresponsive/not Working (4063)
Health Effect - Clinical Codes	Cardiac Arrest (1762); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer contacted stryker to report that their device alarmed and paused during an intervention with a patient.Additionally, it was reported that the control buttons on the device were unresponsive.In this state the device would not be able to provide compressions.If a device does malfunction, the device operating instructions indicate that the user is to perform manual chest compressions.The patient involved in the reported event is deceased; however, the customer advised stryker that the device use did not contribute to the outcome of the patient.
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.The customer provided stryker with the available patient information.Patient fields in which information is not provided were intentionally left blank.Stryker 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.

• Brand Name: LUCAS 2 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: 24108956
• Report Number: 3005445717-2026-00022
• Device Sequence Number: 17596450
• Product Code: DRM
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K090422
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/18/2026

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 2
• Device Catalogue Number: 99576-000024
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/09/2026
• Supplement Date Received by Manufacturer: 05/15/2026
• Initial Report FDA Received Date: 01/19/2026
• Supplement Report FDA Received Date: 05/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/23/2012
• 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 Age: 77 YR
• Patient Sex: Male