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

Model Number LUCAS

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pulmonary Edema (2020)

Event Date 01/06/2023

Event Type  Death  

Event Description

It was reported to stryker that a 57 year-old patient with a cardiac arrest received chest compressions from a lucas device and developed fulminant sepsis secondary to lung contusions and a necrotizing pulmonary infection.The patient associated with the reported event did not survive.This was found during a literature review.

Manufacturer Narrative

Stryker contacted the customer to request additional information on the patient.No response has been received from the customer.Patient fields in which information is not provided were intentionally left blank.Stryker performed a clinical review regarding the reported issue.And, it was concluded that it is likely that lucas caused the lung contusion, but the lucas compressions were not likely to be the cause to the sepsis and necrotizing pulmonary infection.Regarding the comment about safety and efficacy of lucas, especially in obese patients we are not able to comment on.There are + 500 publications with lucas, from randomized controlled trials to case report and this is the first time we hear anything about the safety and efficacy in obese patients.The device was not returned to stryker for evaluation.The cause of the reported issue could not be established.

• Brand Name: LUCAS¿ CPR CHEST COMPRESSION SYSTEM
• Type of Device: 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: 19134295
• MDR Text Key: 340499223
• Report Number: 0003015876-2024-00962
• Device Sequence Number: 1
• Product Code: DRM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161768
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/26/2024,04/18/2024

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?: No
• Device Operator: Health Professional
• Device Model Number: LUCAS
• Device Catalogue Number: UNK_LUN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/26/2024
• Device Age: 2 YR
• Event Location: Hospital
• Date Report to Manufacturer: 03/26/2024
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/18/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 57 YR
• Patient Sex: Male