MAUDE Adverse Event Report: Jolife AB - 3005445717 LUCAS 3 CHEST COMPRESSION SYSTEM; Compressor, Cardiac, External

Model Number	LUCAS 3
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Vascular Problem (4441)
Date of Event	06/04/2026
Type of Reportable Event	Serious Injury
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.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.Patient fields in which information is not provided were intentionally left blank.Stryker performed an initial clinical review of the reported event and determined the device contribution to the patient outcome is unknown.
Event or Problem Description
The customer contacted stryker to report that their lucas device potentially cause an internal thoracic artery injury.
Event or Problem Description
The customer contacted stryker to report that their lucas device potentially caused an internal thoracic artery injury.
Event or Problem Description
The customer contacted stryker to report that their lucas device potentially caused an internal thoracic artery injury.
Additional Manufacturer Narrative
Additional information was received from the customer and a new clinical review was completed.The facility physician informed stryker that the patient died and that there could be a casual relationship between the injury and death.
Additional Manufacturer Narrative
Stryker evaluated the device and was unable to duplicate or verify any device problem relevant to the reported issue.After completing other unrelated repairs, proper device operation was observed through functional and performance testing.The device was returned to the customer for use.No device problem was found.

• Brand Name: LUCAS 3 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: 25663149
• Report Number: 3005445717-2026-00193
• Device Sequence Number: 10379338
• 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: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,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?: Yes
• Is this a Product Problem Report?: No
• 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: 06/26/2026
• 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: 06/04/2026
• Supplement Date Received by Manufacturer: 08/13/2026; 09/17/2026
• Initial Report FDA Received Date: 06/30/2026
• Supplement Report FDA Received Date: 09/02/2026; 09/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/23/2020
• 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
• Outcome Attributed to Adverse Event: Death; Required Intervention
• Patient Sex: Unknown