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

Model Number	LUCAS
Medical Device Problem Codes	Device Alarm System (1012); Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/30/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer did not provide the serial number of the device, therefore g4 pma/510(k) and h4 manufacturing date were left blank intentionally.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
A customer contacted stryker to report that their device alarmed and paused.In this state the device would not be able to perform automated chest compressions.If a device malfunctions, the device operating instructions indicate that the user is to remove the device and immediately start manual chest compressions.There was no report of patient use associated with the reported event.
Event or Problem Description
A customer contacted stryker to report that their device alarmed and paused.In this state the device would not be able to perform automated chest compressions.If a device malfunctions, the device operating instructions indicate that the user is to remove the device and immediately start manual chest compressions.There was no report of patient use associated with the reported event.
Additional Manufacturer Narrative
The sn of the reported device was provided.The record has been updated accordingly.A stryker service representative performed evaluation of the customer¿s device and was able to verify the reported issue.After replacing the compression module, proper device operation was observed through functional and performance testing.The device was subsequently returned to the customer.
Event or Problem Description
A customer contacted stryker to report that their device alarmed and paused.In this state the device would not be able to perform automated chest compressions.If a device malfunctions, the device operating instructions indicate that the user is to remove the device and immediately start manual chest compressions.There was no report of patient use associated with the reported event.
Additional Manufacturer Narrative
Stryker further evaluated the faulty compression module at the product analyses center (pac) and the cause of the reported issue was determined to be due to damaged protective pot.The part was archived by stryker.

• Brand Name: LUCAS 3 CHEST COMPRESSION SYSTEM
• Common Device Name: COMPRESSOR, CARDIAC, EXTERNAL/ DRM
• 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: 23897385
• Report Number: 3005445717-2025-00071
• Device Sequence Number: 5030566
• Product Code: DRM
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/29/2026

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
• Device Catalogue Number: 99576-000067
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/01/2025
• Supplement Date Received by Manufacturer: 01/13/2026; 04/26/2026
• Initial Report FDA Received Date: 12/26/2025
• Supplement Report FDA Received Date: 02/05/2026; 04/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/07/2023
• 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