MAUDE Adverse Event Report: JOLIFE AB - 3005445717 LUCAS 2, 2.2, IN SHIPPING BOX,EN,DA,SV,FI,NO; COMPRESSOR, CARDIAC, EXTERNAL

Model Number LUCAS

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

Patient Problems Bone Fracture(s) (1870); Liver Laceration(s) (1955)

Event Date 03/01/2020

Event Type  Injury  

Manufacturer Narrative

This mdr is being submitted to correct the incorrect manufacturing site and related fields that were previously submitted under mfr 3005445717-2020-00004.Physio-control performed an clinical review and determined that based on the available information, the device use may have contributed to the patient outcome.It can not be excluded that the liver lacerations occur when providing chest compressions during both manual and mechanical cpr.Rib fractures and other injuries are common but acceptable consequences of cpr given the alternative of death from cardiac arrest.Not returned to manufacturer.

Event Description

The customer contacted physio-control to report that their device had potentially caused liver laceration, a broken rib, and refractory bleeding, during patient use.

• Brand Name: LUCAS 2, 2.2, IN SHIPPING BOX,EN,DA,SV,FI,NO
• 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: 16244025
• MDR Text Key: 308129925
• Report Number: 0003015876-2023-00137
• Device Sequence Number: 1
• Product Code: DRM
• Combination Product (y/n): N
• Reporter Country Code: FI
• PMA/PMN Number: K090422
• 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: 03/26/2020,01/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2023
• 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: 99576-000026
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/26/2020
• Distributor Facility Aware Date: 03/01/2020
• Device Age: 5 YR
• Event Location: Hospital
• Date Report to Manufacturer: 03/03/2020
• Date Manufacturer Received: 03/03/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/03/2017
• 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): Hospitalization
• Patient Age: 34 YR
• Patient Sex: Female
• Patient Weight: 70 KG