MAUDE Adverse Event Report: Jolife AB - 3005445717 LUCAS ® CPR CHEST COMPRESSION SYSTEM; Compressor, Cardiac, External

Model Number	LUCAS 3
Medical Device Problem Code	Key or Button Unresponsive/not Working (4063)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/17/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Stryker evaluated the customer's device and was able to duplicate the reported issue.After replacing the hood, 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 that the control panels 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.There was no patient use associated with the reported event.
Event or Problem Description
A customer contacted stryker to report that the control panels 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.There was no patient use associated with the reported event.
Additional Manufacturer Narrative
Stryker further evaluated the replaced hood at the product analysis center (pac) and the root cause of the reported issue was determined to be unseated keypad flex cable.

• Brand Name: LUCAS ® 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: juan salazar ; 11811 willows road ne; redmond, WA 98052 ; +1(425)867-4000
• MDR Report Key: 25162659
• Report Number: 3005445717-2026-00144
• Device Sequence Number: 16112777
• Product Code: DRM
• UDI-Device Identifier: 00883873834329
• UDI-Public: 00883873834329
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,Followup
• Report Date (Section B): 09/17/2026

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
• Date Returned to Manufacturer: 04/17/2026
• 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: 04/17/2026
• Supplement Date Received by Manufacturer: 09/04/2026
• Initial Report FDA Received Date: 05/13/2026
• Supplement Report FDA Received Date: 09/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/25/2024
• 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