MAUDE Adverse Event Report: Physio-Control, Inc. - 3015876 LUCAS 2 CHEST COMPRESSION SYSTEM; Compressor, Cardiac, External

Model Number	Lucas 2
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2025
Type of Reportable Event	Malfunction

• Brand Name: LUCAS 2 CHEST COMPRESSION SYSTEM
• Common Device Name: Compressor, Cardiac, External
• Manufacturer (Section D): Physio-Control, Inc. - 3015876; 11811 willows road ne; redmond WA 98052
• Manufacturer (Section G): Jolife AB - 3005445717; scheelevagen 17; ideon science park; lund SE-22 3 70; SW SE-223 70
• Manufacturer Contact: juan salazar ; 11811 willows road ne; redmond, WA 98052 ; +1(425)867-4000
• MDR Report Key: 50170810
• Report Number: 0003015876-2026-01580
• Device Sequence Number: 9880013
• Product Code: DRM
• UDI-Device Identifier: 00883873904565
• UDI-Public: 00883873904565
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K090422
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/29/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: Lucas 2
• Device Catalogue Number: 99576-000024
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/01/2025
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 07/01/2025
• Supplement Date Received by Manufacturer: 09/03/2026
• Initial Report FDA Received Date: 08/07/2026
• Supplement Report FDA Received Date: 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/02/2015
• 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
• Patient Sex: Unknown