MAUDE Adverse Event Report: PHYSIO-CONTROL, INC. - 3015876 LUCAS 3 CHEST COMPRESSION SYSTEM; COMPRESSOR, CARDIAC, EXTERNAL

Model Number	LUCAS
Medical Device Problem Code	Sharp Edges (4013)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/25/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Stryker contacted the customer to request additional information on the patient.Stryker requests patient information necessary for regulatory compliance, strictly adhering to hipaa's privacy rule.No additional patient information has been provided.Patient fields in which information is not provided were intentionally left blank.Stryker continues to investigate the reported failure 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 during the use of their lucas device, the device's suction cup became damaged, causing a 1-2 cm wound to the patient's chest.
Event or Problem Description
The customer contacted stryker to report that during the use of their lucas device, the device's suction cup became damaged, causing a 1-2 cm wound to the patient's chest.
Additional Manufacturer Narrative
Stryker performed a clinical review of the reported event and determined that it is likely that the wound on the patient's chest was caused by compressions from the device.It is not likely that the wound on the chest contributed to any adverse patient outcome.
Additional Manufacturer Narrative
The device was not returned to stryker for evaluation.The cause of the reported issue could not be determined.
Event or Problem Description
The customer contacted stryker to report that during the use of their lucas device, the device's suction cup became damaged, causing a 1-2 cm wound to the patient's chest.

• Brand Name: LUCAS 3 CHEST COMPRESSION SYSTEM
• Common Device Name: COMPRESSOR, CARDIAC, EXTERNAL
• Manufacturer (Section D): PHYSIO-CONTROL, INC. - 3015876; 11811 willows road ne; ideon science park; redmond WA 98052
• Manufacturer (Section G): PHYSIO-CONTROL, INC. - 3015876; 11811 willows road ne; ideon science park; redmond WA 98052
• Manufacturer Contact: brian blakeslee ; 11811 willows road ne; redmond, WA 98052 ; 4258674000
• MDR Report Key: 21208204
• Report Number: 0003015876-2025-00134
• Device Sequence Number: 8109464
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/29/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/25/2024
• Supplement Date Received by Manufacturer: 01/23/2025; 05/12/2025
• Initial Report FDA Received Date: 01/22/2025
• Supplement Report FDA Received Date: 01/28/2025; 05/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/17/2021
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown