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

Model Number LUCAS 2

Device Problem Power Problem (3010)

Patient Problem Insufficient Information (4580)

Event Date 08/31/2021

Event Type  malfunction  

Event Description

At 8 o'clock in the morning on (b)(6) 2021 emergency department staff conducted routine maintenance tests on the resuscitation machine.The switch of the ventilator was turned on, it was plugged in ac power, and the routine test was performed.During the test, it was found that the resuscitation machine had no response, and the equipment department was immediately called for informing.After the equipment department engineer arrived at the site, the power cord was measured, the output dc 24v voltage was normal, the resuscitator battery was replaced, and the resuscitator still failed to work normally.The factory engineer was immediately contacted, and the engineer said that the main control board of the internal power supply was damaged and needed to be replaced.After the main control board was replaced, it was restarted for a test and the instrument returned to normal.(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: 17529460
• MDR Text Key: 321436082
• Report Number: MW5136386
• 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