MAUDE Adverse Event Report: JOLIFE AB - 3005445717 LUCAS ® CPR 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	Laceration(s) (1946)
Date of Event	05/13/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Stryker evaluated the customer's device and was unable to duplicate the reported issue.Proper device operation was observed through functional and performance testing.The device was returned to the customer for use.A clinical review was performed and it was determined that the device use may have caused or contributed to the reported laceration.Stryker contacted the customer to request additional information on the patient.The customer provided stryker with the available patient information.
Event or Problem Description
It was reported, lucas 2 device was being used on a patient for chest compressions and it put a 2 inch laceration in the patient's chest.
Event or Problem Description
It was reported, lucas 2 device was being used on a patient for chest compressions and it put a 2 inch laceration in the patient's chest.
Additional Manufacturer Narrative
Corrected g3 for reportability awareness date.

• Brand Name: LUCAS ® CPR 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): PHYSIO-CONTROL, INC. - 3015876; 11811 willows road ne; ideon science park; redmond WA 98052
• Manufacturer Contact: brian blakeslee ; 11811 willows road ne; redmond, WA 98052 ; 4258674000
• MDR Report Key: 19387792
• Report Number: 0003015876-2024-01715
• Device Sequence Number: 7101340
• Product Code: DRM
• UDI-Device Identifier: 00883873904565
• UDI-Public: 00883873904565
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/30/2024
• Report Date (Section F): 05/13/2024

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: 05/17/2024
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/13/2024
• Device Age: 10 YR
• Event Location: Hospital
• Date Report to Manufacturer: 05/13/2024
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 05/13/2024
• Initial Report FDA Received Date: 05/23/2024
• Supplement Report FDA Received Date: 06/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/20/2014
• 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 Sex: Unknown