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

Model Number	LUCAS 3
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 the device alarmed and paused.In this state, a delay in cardiopulmonary resuscitation may occur.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 patient use associated with the reported event.
Additional Manufacturer Narrative
A third-party service agent performed an evaluation of the customer¿s device and was unable to duplicate the reported issue.The technician reviewed the device log and was able to verify the reported issue.Compression module and bellows were replaced as preventative maintenance measure.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 the device alarmed and paused.In this state, a delay in cardiopulmonary resuscitation may occur.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 patient use associated with the reported event.

• Brand Name: LUCAS 3 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: 23987668
• Report Number: 3005445717-2026-00007
• Device Sequence Number: 21489461
• Product Code: DRM
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K173553
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/15/2026

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 3
• Device Catalogue Number: 99576-000067
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/17/2025
• Supplement Date Received by Manufacturer: 05/14/2026
• Initial Report FDA Received Date: 01/07/2026
• Supplement Report FDA Received Date: 05/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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