MAUDE Adverse Event Report: JOLIFE AB LUCAS 2; COMPRESSOR, CARDIAC, EXTERNAL

Model Number LUCAS 2

Device Problem Mechanical Problem (1384)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/18/2019

Event Type  malfunction  

Event Description

Patient was being coded and a cpr lucas device was being used to automate compressions, during a time of pause the machine would not pause.Staff immediately pulled the battery out of the machine as to not delay the pause.When compressions were to start again the battery was inserted and the machine would not start.Manual compressions were started immediately, and the machine was taken out of service.

• Brand Name: LUCAS 2
• Type of Device: COMPRESSOR, CARDIAC, EXTERNAL
• Manufacturer (Section D): JOLIFE AB; 2825 airview blvd; portage MI 49002
• MDR Report Key: 9664598
• MDR Text Key: 177595971
• Report Number: 9664598
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: LUCAS 2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/27/2019
• Device Age: 9 YR
• Event Location: Hospital
• Date Report to Manufacturer: 02/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1