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

Model Number	LUCAS
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Skin Tears (2516)
Date of Event	12/24/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.A clinical review was performed for this case: device use may have caused the reported wound on the patient chest, but did not contribute to the patient outcome (death).As per lucas operating instructions "skin, abrasions, bruising and soreness of the chest are common during the use of the lucas chest compression system.¿ stryker continues to investigate the reported issue 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 that a wound was observed on the patient's chest while using the device.The patient involved in the reported event did not survive, however it was determined that the device did not cause the death of the patient.It was reported that the patient was victim of a homicide.
Event or Problem Description
The customer contacted stryker to report that a wound was observed on the patient's chest while using the device.The patient involved in the reported event did not survive, however it was determined that the device did not cause the death of the patient.It was reported that the patient was victim of a homicide.
Additional Manufacturer Narrative
There was no device malfunctioned reported, therefore the customer did not return the device to stryker for evaluation.A cause of the reported issue could not be determined.
Event or Problem Description
The customer contacted stryker to report that a wound was observed on the patient's chest while using the device.The patient involved in the reported event did not survive, however it was determined that the device did not cause the death of the patient.It was reported that the patient was victim of a homicide.
Additional Manufacturer Narrative
Stryker received an update on event date and patient's age.Section b3 and a2 have been updated accordingly.

• 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: 21663376
• Report Number: 3005445717-2025-00002
• Device Sequence Number: 20748818
• 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
• Report Date (Section B): 07/15/2025

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
• Device Catalogue Number: 99576-000067
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/07/2025
• Supplement Date Received by Manufacturer: 07/10/2025; 07/10/2025
• Initial Report FDA Received Date: 03/21/2025
• Supplement Report FDA Received Date: 07/14/2025; 07/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Other
• Patient Age: 55 YR
• Patient Sex: Male