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	04/29/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer contacted stryker to report that their device alarmed and paused.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.There was no patient involvement reported with the event.
Additional Manufacturer Narrative
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 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): Physio-Control, Inc. - 3015876; 11811 willows road ne; ideon science park; redmond WA 98052
• Manufacturer Contact: juan salazar ; 11811 willows road ne; redmond, WA 98052 ; +1(425)867-4000
• MDR Report Key: 25214280
• Report Number: 3005445717-2026-00149
• Device Sequence Number: 10750019
• Product Code: DRM
• UDI-Device Identifier: 00883873834282
• UDI-Public: 00883873834282
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K173553
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/21/2026

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: 99576-000067
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/15/2026
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/29/2026
• Supplement Date Received by Manufacturer: 09/11/2026
• Initial Report FDA Received Date: 05/19/2026
• Supplement Report FDA Received Date: 09/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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