MAUDE Adverse Event Report: JOLIFE AB - 3005445717 LUCAS 2 CHEST COMPRESSION SYSTEM; COMPRESSOR, CARDIAC, EXTERNAL

Model Number LUCAS

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

Patient Problem Cardiac Perforation (2513)

Event Date 09/12/2021

Event Type  Death  

Event Description

The customer contacted stryker to report that their cpr device was used on a patient, however the patient did not survive.At confirmation of the death of the patient, a ct scan of patient revealed that the aorta was damaged.In addition, because the cpr device had continued compression until the patient death was confirmed while the sternum height of the dead body was about 13-14cm, which was less than 17cm as the minimum value of the usable sternum height, the hospital requests that stryker to investigate if the cpr device worked without problem when it was used for the patient.The doctor said that since the patient had cardiogenic disease, it was foreseeable that she would die sooner or later, but we can neither confirm nor deny whether or not this vascular injury hastened her death.

Manufacturer Narrative

Stryker evaluated the customer's device and could not duplicate or verify the reported issue.The device functioned properly.After other unrelated repairs were completed, proper device operation was observed through functional and performance testing.The device was returned to the customer for use.The cause of the reported issue could not be determined.A clinical review of the reported event was performed.The clinical review concluded, "with the information received it can not be excluded that lucas could have caused the damage to the aorta.However, it can neither confirm nor deny whether this damage to the aorta hastened the patient`s death.".

• Brand Name: LUCAS 2 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: dara friedman ; 11811 willows road ne; redmond, WA 98052 ; 4258674000
• MDR Report Key: 18044009
• MDR Text Key: 327016637
• Report Number: 3005445717-2023-00051
• Device Sequence Number: 1
• Product Code: DRM
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K090422
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2023
• 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: 99576-000029
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/24/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/15/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/24/2016
• 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: 70 YR
• Patient Sex: Female