MAUDE Adverse Event Report: JOLIFE AB / PHYSIOCONTROL LUCAS 2

Model Number LUCAS 2

Device Problem Device Inoperable (1663)

Patient Problem Cardiac Arrest (1762)

Event Date 10/29/2016

Event Type  malfunction  

Event Description

Lucas 2 automatic chest compression device failed during operation on a pt in cardiac arrest.

• Brand Name: LUCAS 2
• Type of Device: LUCAS 2
• Manufacturer (Section D): JOLIFE AB / PHYSIOCONTROL; ideon science park ; lund SE-22 3 70; SW SE-223 70
• MDR Report Key: 6080905
• MDR Text Key: 59455212
• Report Number: MW5065824
• Device Sequence Number: 1
• Product Code: DRM
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/03/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 65 YR
• Patient Weight: 68