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

Model Number LUCAS 2

Device Problem Protective Measures Problem (3015)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

During use, there was a freeze, anc t e device emitted a mc1 a1arm sound.It was suspected that the bearing problem led to unbalanced pressing, and the pressing appeared stuck and triggered an alarm.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: LUCAS 2
• Type of Device: COMPRESSOR, CARDIAC, EXTERNAL
• Manufacturer (Section D): PHYSIO-CONTROL
• MDR Report Key: 17523802
• MDR Text Key: 321255547
• Report Number: MW5130750
• 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: 12/01/2021

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?: No
• Device Model Number: LUCAS 2
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2023
• Patient Sequence Number: 1