MAUDE Adverse Event Report: Jolife AB - 3005445717 LUCAS ® CPR Chest Compression System; Compressor, Cardiac, External / DRM

Model Number	LUCAS
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	09/02/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer contacted stryker to report that their lucas device was unable to secure to the backplate of the device.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
The serial number provided does show to be valid, therefore h4 manufacturing date is intentionally left blank.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.

• Brand Name: LUCAS ® CPR 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: juan salazar ; 11811 willows road ne; redmond, WA 98052 ; +1(425)867-4000
• MDR Report Key: 50863227
• Report Number: 3005445717-2026-00424
• Device Sequence Number: 9223345
• Product Code: DRM
• UDI-Device Identifier: 00883873834282
• UDI-Public: 00883873834282
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K161768
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/22/2026

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?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 09/03/2026
• Initial Report FDA Received Date: 09/23/2026
• 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