MAUDE Adverse Event Report: JOLIFE AB - 3005445717 LUCAS 2 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 Codes	Skin Tears (2516); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/17/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer contacted stryker to report that the use of their device caused damage to the chest of the patient.
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.Stryker evaluated the customer's device and no issues were found with the device.Stryker installed new suction cup, patient straps, and greased the carry ball screw as part of the preventative maintenance.After observing proper device operation through functional and performance testing, the device was returned to the customer for use.
Event or Problem Description
The customer contacted stryker to report that the use of their device caused damage to the chest of the patient.The customer confirmed that the device use did not contribute to the outcome of the patient.
Additional Manufacturer Narrative
The customer provided stryker with some of the patient information.The applicable patient fields have been updated.The customer also confirmed that the device use did not contribute to the outcome of the patient.
Additional Manufacturer Narrative
Stryker performed a clinical review of the reported event and determined that although the device did not contribute to the outcome of the patient, the device likely caused the reported injury.
Event or Problem Description
The customer contacted stryker to report that the use of their device caused damage to the chest of the patient.The patient is deceased; however, the customer confirmed that the device use did not contribute to the outcome of the patient.

• 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: brian blakeslee ; 11811 willows road ne; redmond, WA 98052 ; 4258674000
• MDR Report Key: 20687947
• Report Number: 0003015876-2024-03164
• Device Sequence Number: 15599474
• Product Code: DRM
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K090422
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Importer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/06/2026
• Report Date (Section F): 11/14/2024

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: LUCAS
• Device Catalogue Number: 99576-000024
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2024
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/17/2024
• Device Age: 10 YR
• Event Location: Hospital
• Date Report to Manufacturer: 10/18/2024
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 11/20/2024; 04/02/2026
• Initial Report FDA Received Date: 11/14/2024
• Supplement Report FDA Received Date: 12/13/2024; 04/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/14/2015
• 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: 82 YR
• Patient Sex: Female
• Patient Weight: 54 KG
• Date Report Sent to FDA: 11/14/2024