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

Device Problems Overheating of Device (1437); Failure to Power Up (1476); Noise, Audible (3273)

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

Event Type  malfunction  

Event Description

Powering the unit on caused a gear grinding sound and the unit would not run, after powering the unit off and on a few times it seemed to function properly; however after the call the battery was noticed to be very hot.The unit was taken out of service.Fda safety report id# (b)(4).

• Brand Name: LUCAS 2
• Type of Device: COMPRESSOR, CARDIAC, EXTERNAL
• MDR Report Key: 9098446
• MDR Text Key: 159747290
• Report Number: MW5089944
• Device Sequence Number: 1
• Product Code: DRM
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 75 YR