MAUDE Adverse Event Report: JOLIFE AB - 3005445717 LUCAS 3 CHEST COMPRESSION SYSTEM; COMPRESSOR, CARDIAC, EXTERNAL

Model Number	3
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Liver Laceration(s) (1955)
Date of Event	04/11/2025
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.
Event or Problem Description
The customer contacted stryker to report a patient death.Use of the device may have contributed but it is unknown how the injury contributed.
Additional Manufacturer Narrative
Partial patient information was received, section a has been updated.Stryker evaluated the customer's device and was not able to verify or duplicate the reported issue.After observing proper device operation through functional and performance testing, the device was returned to the customer for use.The cause of the reported issue could not be determined.Stryker performed a 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 a patient death.Use of the device may have contributed but it is unknown how the injury contributed.
Event or Problem Description
The customer contacted stryker to report a patient death.Use of the device may have contributed but it is unknown how the injury contributed.
Additional Manufacturer Narrative
The device serial number and manufacture date have been provided.
Additional Manufacturer Narrative
B1 has been corrected to adverse event.H1 has been corrected to death.
Event or Problem Description
The customer contacted stryker to report a patient death.Use of the device may have contributed but it is unknown how the injury contributed.

• 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; ideon science park; redmond, WA 98052 ; 4258674000
• MDR Report Key: 21994998
• Report Number: 3005445717-2025-00004
• Device Sequence Number: 8312833
• Product Code: DRM
• UDI-Device Identifier: 00883873834282
• UDI-Public: 00883873834282
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K173553
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 04/09/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 3
• Device Catalogue Number: 99576-000067
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/11/2025
• Supplement Date Received by Manufacturer: 08/14/2025; 08/14/2025; 04/08/2026
• Initial Report FDA Received Date: 05/09/2025
• Supplement Report FDA Received Date: 08/21/2025; 02/04/2026; 04/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/02/2024
• 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 Age: 72 YR
• Patient Sex: Male