MAUDE Adverse Event Report: JOLIFE AB - 3005445717 LUCAS 2, 2.2, IN SHIPPING BOX, EN; COMPRESSOR, CARDIAC, EXTERNAL

Model Number LUCAS

Device Problem Mechanical Problem (1384)

Patient Problem Cardiac Arrest (1762)

Event Date 01/06/2021

Event Type  Death  

Manufacturer Narrative

This mdr is being submitted to correct the incorrect manufacturing site and related fields that were previously submitted under mfr # 0003015876-2021-00266.Physio-control contacted the customer to request additional information on the patient.The customer provided physio-control with the available patient information.Patient fields in which information is not provided were intentionally left blank.Physio-control evaluated the customers device and was unable to duplicate the reported issue.

Event Description

The customer contacted physio-control to report that their device ceased to provide mechanical chest compressions while in use with a patient.Manual cpr was provided after the lucas stopped.The patient is deceased.The issue is patient related.The customer indicated that it is unknown if the device use caused or contributed to the reported death.

• Brand Name: LUCAS 2, 2.2, 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: 16224202
• MDR Text Key: 307900736
• Report Number: 3005445717-2023-00019
• Device Sequence Number: 1
• Product Code: DRM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K090422
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 99576-000024
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/07/2021
• Initial Date FDA Received: 01/23/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/14/2013
• 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: 71 YR
• Patient Sex: Female
• Patient Weight: 165
• Patient Race: Black Or African American