MAUDE Adverse Event Report: Jolife AB - 3005445717 LUCAS 2 CHEST COMPRESSION SYSTEM; Compressor, Cardiac, External

Model Number	LUCAS 2
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/31/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer contacted stryker to report that their device alarmed and stopped.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
A stryker field service representative evaluated the device and duplicated the reported issue.The drive belt was replaced to resolve the issue.After completing other unrelated repairs, proper device operation was observed through functional and performance testing and the device was returned to the customer for service.

• Brand Name: LUCAS 2 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: 50852444
• Report Number: 3005445717-2026-00421
• Device Sequence Number: 13242605
• Product Code: DRM
• UDI-Device Identifier: 00883873904565
• UDI-Public: 00883873904565
• 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: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/22/2026

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?: Yes
• Date Returned to Manufacturer: 09/04/2026
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 09/03/2026
• Initial Report FDA Received Date: 09/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/16/2013
• 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