MAUDE Adverse Event Report: UNKNOWN LUCAS II CHEST COMPRESSION SYSTEM; COMPRESSOR, CARDIAC, EXTERNAL

Model Number LUCAS II

Device Problem Noise, Audible (3273)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/11/2022

Event Type  malfunction  

Event Description

On (b)(6) 2022, the nurse routinely tested the chest compression system, and when it was operating in automatic compression mode, a state of abnormal sound appeared from time to time.It was immediately reported to the engineer of the device department for maintenance, which did not cause any adverse consequences.This device was used for many years and the expiration date could not be traced back.Situation of combined medication/device: none (b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: LUCAS II CHEST COMPRESSION SYSTEM
• Type of Device: COMPRESSOR, CARDIAC, EXTERNAL
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 17488880
• MDR Text Key: 320711840
• Report Number: MW5121579
• 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: 12/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Model Number: LUCAS II
• Patient Sequence Number: 1