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

Model Number LUCAS

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

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/22/2022

Event Type  Death  

Manufacturer Narrative

Stryker received additional patient information from the customer.The customer provided stryker with the available patient information.Patient fields in which information is not provided were intentionally left blank.Stryker performed a clinical review regarding the reported issue.As described, rib fractures and injuries to the liver occur with both manual and mechanical cpr.With the limited data provided in this case, it cannot be excluded that lucas compressions caused rib fractures and liver injury.

Event Description

The customer contacted stryker to report that their device use resulted in the patient being injured with ribs fracture and liver damage.The involved patient ultimately did not survive.

Manufacturer Narrative

The device was not returned to stryker for evaluation.The cause of the reported issue could not be determined.

Event Description

The customer contacted stryker to report that their device use resulted in the patient being injured with ribs fracture and liver damage.The involved patient ultimately did not survive.

• Brand Name: LUCAS¿ CPR CHEST COMPRESSION SYSTEM
• Type of Device: 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: todd bandy ; 11811 willows road ne; redmond, WA 98052 ; 4258674000
• MDR Report Key: 16315528
• MDR Text Key: 309008556
• Report Number: 3005445717-2023-00038
• Device Sequence Number: 1
• Product Code: DRM
• Combination Product (y/n): N
• Reporter Country Code: TH
• PMA/PMN Number: K173553
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 05/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2023
• 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: 99576-000064
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/27/2020
• 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 Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian