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

Model Number	LUCAS 3
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/20/2026
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
The customer contacted stryker to report that the buttons on both arms of the device have come off.This may lead to device not being able to lock to the back plate.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 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): 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: 24242395
• Report Number: 3005445717-2026-00037
• Device Sequence Number: 18726557
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/09/2026

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?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/21/2026
• Supplement Date Received by Manufacturer: 06/09/2026
• Initial Report FDA Received Date: 02/02/2026
• Supplement Report FDA Received Date: 06/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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