MAUDE Adverse Event Report: JOLIFE AB - 3005445717 LUCAS 3, 3.1, IN SHIPPING BOX, EN; COMPRESSOR, CARDIAC, EXTERNAL

Model Number LUCAS

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

Patient Problem Internal Organ Perforation (1987)

Event Date 12/11/2019

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 (b)(4).Physio-control evaluated the customer's device and found no issues with the device.Proper device operation was observed through functional and performance testing, and the device was returned to the customer for use.This type of injury is common during manual cpr, however the clinical review performed was unable to determine if the laceration/perforation was caused by manual or mechanical cpr.

Event Description

The customer contacted physio-control to report that a patient incurred a cpr related laceration/perforation after receiving both manual cpr and cpr by a lucas device.The patient received operative repair and was taken to the icu in critical condition.The patient later expired.

• Brand Name: LUCAS 3, 3.1, IN SHIPPING BOX, EN
• 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: 16243934
• MDR Text Key: 308128112
• Report Number: 0003015876-2023-00135
• 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: User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/10/2020,01/25/2023

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?: Yes
• Device Operator: Health Professional
• Device Model Number: LUCAS
• Device Catalogue Number: 99576-000063
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/10/2020
• Distributor Facility Aware Date: 12/11/2019
• Device Age: 4 YR
• Event Location: Hospital
• Date Report to Manufacturer: 01/09/2020
• Date Manufacturer Received: 12/17/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/05/2018
• 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): Required Intervention
• Patient Age: 57 YR
• Patient Sex: Male
• Patient Weight: 87 KG