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 Codes	Hemorrhage/Blood Loss/Bleeding (1888); Unspecified Respiratory Problem (4464)
Date of Event	06/10/2025
Type of Reportable Event	Death
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 performed a clinical review of the reported event and determined that the device may have contributed to the patient outcome.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.
Event or Problem Description
The customer contacted stryker to report that their device was used on a patient in cardiac arrest.During use of the lucas device, bleeding was observed from the tracheal intubation tube and the nurse reported a suspected lung injury.The patient associated with the reported event did not survive.
Event or Problem Description
The customer contacted stryker to report that their device was used on a patient in cardiac arrest.During use of the lucas device, bleeding was observed from the tracheal intubation tube and the nurse reported a suspected lung injury.The patient associated with the reported event did not survive.
Additional Manufacturer Narrative
Stryker evaluated the device and the reported issue was not able to be verified and was not able to be duplicated.Root cause could not be determined.The device passed functional and performance testing and was returned to the customer.

• 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: brian blakeslee ; 11811 willows road ne; redmond, WA 98052 ; 4258674000
• MDR Report Key: 22372739
• Report Number: 0003015876-2025-01321
• Device Sequence Number: 8226435
• Product Code: DRM
• UDI-Device Identifier: 00883873834282
• UDI-Public: 00883873834282
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K161768
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 11/12/2025

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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/11/2025
• Supplement Date Received by Manufacturer: 10/16/2025
• Initial Report FDA Received Date: 07/01/2025
• Supplement Report FDA Received Date: 11/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/30/2024
• 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
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Female