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

Model Number LUCAS 2

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

During the rescue of the patient, a cardiopulmonary resuscitation machine was used to perform chest compressions.The machine could not perform compressions.The machine was immediately removed and the medical staff manually performed chest compressions.Did not cause adverse consequences to patient.Report for repairs immediately afterwards.(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: 17531458
• MDR Text Key: 321419408
• Report Number: MW5138373
• 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: 12/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Model Number: LUCAS 2
• Patient Sequence Number: 1