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

Model Number LUCAS 2 {CHEST COMPRESSION DEVICE)

Device Problem Defective Device (2588)

Patient Problems Cardiac Arrest (1762); Respiratory Arrest (4461)

Event Type  Death  

Event Description

The patient was sent to our hospital due to cardiac and respiratory arres.The patient's vital characteristics at the time of the event: body temperature 36.4, breathing beats/min, pulse 0 beats/min, blood pressure 0/0mmhg, the peripheral blood oxygen saturation was 0%.When the medical staff used the chest compression system to give cpr to the patient, the chest compression system stopped working after 2 minutes of use.The medical staff immediately performed chest heart compression manually, but the rescue failed.) (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: 17536103
• MDR Text Key: 321039744
• Report Number: MW5142993
• 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: 10/18/2021

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 {CHEST COMPRESSION DEVICE)
• Patient Sequence Number: 1