MAUDE Adverse Event Report: JOLIFE AB LUCAS; COMPRESSOR, CARDIAC, EXTERNAL

Model Number 100582-01

Device Problems Device Difficult to Setup or Prepare (1487); Connection Problem (2900); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Cardiac Arrest (1762)

Event Date 11/21/2022

Event Type  malfunction  

Event Description

Pt arrived via helicopter and came straight to the cath lab.During the procedure, cpr was started, and the lucas was applied.The lucas clasps malfunctioned, and the device was unable to be attached.The clasps would not clip into place on one side of the device.A second lucas was obtained from the icu and was utilized for the procedure.

• Brand Name: LUCAS
• Type of Device: COMPRESSOR, CARDIAC, EXTERNAL
• Manufacturer (Section D): JOLIFE AB; 11811 willows rd ne; redmond WA 98052
• MDR Report Key: 16194054
• MDR Text Key: 307582147
• Report Number: 16194054
• Device Sequence Number: 1
• Product Code: DRM
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 100582-01
• Device Lot Number: 4000077
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/27/2022
• Event Location: Hospital
• Date Report to Manufacturer: 01/18/2023
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 24820 DA
• Patient Sex: Male