MAUDE Adverse Event Report: JOLIFE AB - 3005445717 LUCAS 3 CHEST COMPRESSION SYSTEM; COMPRESSOR, CARDIAC, EXTERNAL

Model Number LUCAS 3

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

Patient Problems Bruise/Contusion (1754); Hemorrhage/Bleeding (1888); Laceration(s) (1946)

Event Date 04/06/2021

Event Type  Death  

Event Description

A customer contacted physio-control to report that some injuries associated with resuscitation were noted at post-mortem of the patient.It was observed that the patient had chest hemorrhage with ascending aorta adventitial dissection with cardiac tamponade, pericardial tearing with myocardial hemorrhage and bruising.The patient associated with the reported event did not survive.

Manufacturer Narrative

This mdr is being submitted to correct the incorrect fda registration number that was previously submitted under uf/importer report number # 3005445717-2021-00006.A stryker clinical specialist performed a clinical review and it was determined that due to lack of information it can not be excluded or confirmed that the reported injuries could have been caused by cpr, manual or mechanical.The customer was contacted numerous times for more details, but no response appears to be forthcoming.The device has not been returned to physio-control for evaluation for this reported issue.The reported issue could not be verified and the cause of the reported issue could not be determined.The device has not been returned to stryker for evaluation for this reported issue.The reported issue could not be verified and the cause of the reported issue could not be determined.The device was evaluated in august 2021 and the device passed all functional and performance testing.

• Brand Name: LUCAS 3 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: todd bandy ; 11811 willows road ne; redmond, WA 98052 ; 4258674000
• MDR Report Key: 16214951
• MDR Text Key: 307793377
• Report Number: 0003015876-2023-00097
• Device Sequence Number: 1
• Product Code: DRM
• Combination Product (y/n): N
• Reporter Country Code: EI
• PMA/PMN Number: K161768
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Source Type: Foreign
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/12/2021,01/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: LUCAS 3
• Device Catalogue Number: 99576-000065
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/12/2021
• Distributor Facility Aware Date: 04/06/2021
• Device Age: 3 YR
• Event Location: Hospital
• Date Report to Manufacturer: 04/13/2021
• Date Manufacturer Received: 04/13/2021
• Was Device Evaluated by Manufacturer?: No
• 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: 64 YR
• Patient Sex: Male