MAUDE Adverse Event Report: Jolife AB - 3005445717 LUCAS 2, 2.2, IN SHIPPING BOX, EN; 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, 2.2, IN SHIPPING BOX, EN
• 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: juan salazar ; 11811 willows road ne; redmond, WA 98052 ; +1(425)867-4000
• MDR Report Key: 50916254
• Report Number: 3005445717-2026-00429
• Device Sequence Number: 5344881
• 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
• Report Date (Section B): 09/28/2026

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
• Initial Report FDA Received Date: 09/28/2026
• 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