TCM COMBIM MODULE

Additional Manufacturer Narrative

DATE OF EVENT IS ESTIMATED.

Description of Event or Problem

ACCORDING TO THE COMPLAINT, THE CUSTOMER NOTICED THAT SMOKE COMING OUT THE TCM COMBIM (SERIAL NUMBER: (B)(6) WHEN PREPARING THE MONITOR FOR USE. THE CUSTOMER CONFIRMS THAT NO ADVERSE EVENTS OCCURRED.

Additional Manufacturer Narrative

DURING AN INTERNAL REVIEW ON 2024-05-15 IT WAS FOUND THAT THE ESTIMATED DATE OF EVENT SHOULD BE CHANGED TO AN EARLIER ESTIMATION (B)(6) 2024. ON 2024-05-07 INVESTIGATION WAS FINALIZED AS MENTIONED IN FU2 MDR SENT ON 2024-05-08, AS THE INVESTIGATION WAS FINALIZED WITH THE CONCLUSION THAT THE PRODUCT DID NOT MALFUNCTION AND WAS DUE TO USER ERROR. THIS INCIDENT DOES NOT MEET THE CRITERIA OF A REPORTABLE MDR NOW.

Additional Manufacturer Narrative

H6: UPDATED WITH CORRECT A-CODES.

Additional Manufacturer Narrative

IN THE INITIAL MDR THE SERIAL NUMBER AND UDI WAS ADDED FOR A DEVICE COMPONENT. THE CORRECT DATA IS: BRAND NAME: TCM COMBIM MODULE. MODEL/CATALOG NUMBER: 903-111. COMPONENT NAME AND MODEL/CATALOG NUMBER: BASE UNIT, 391-880. COMPONENT SERIAL NO.: (B)(6). UDI: NOT APPLICABLE. THE DEVICE WAS MANUFACTURED PRIOR TO UDI REQUIREMENTS. THE ROOT CAUSE ANALYSIS CONCLUDED THAT THE ISSUE IS CAUSED BY USE ERROR. THE INVESTIGATION WAS CONDUCTED BASED ON PICTURES OF THE DEVICE AND INSPECTION OF THE DEVICE, WHICH REVEALED LARGE AMOUNTS OF DUST INSIDE THE DEVICE, PREVENTING ADEQUATE VENTILATION AND COOLING OF THE DEVICE AND ITS ELECTRONIC COMPONENTS. IT WAS CONCLUDED THAT THE SMOKE WAS ORIGINATED FROM THE ELECTRONICS OF POWER SUPPLY UNIT OVERHEATING DUE TO INADEQUATE VENTILATION THAT RESULTED IN REDUCED THERMAL MANAGE-MENT EFFECTIVENESS FROM EXCESSIVE AMOUNTS OF DUST. THE PRODUCT'S INSTRUCTIONS FOR USE INCLUDE A VENTILATION REQUIREMENT OF LOCATING THE DEVICE IN A WELL-VENTILATED DUST-FREE ATMOSPHERE.