MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. MULTIDIAGNOST ELEVA; SYSTEM, X-RAY, ANGIOGRAPHIC

Model Number MULTIDIAGNOST ELEVA

Device Problems Overheating of Device (1437); Temperature Problem (3022)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/15/2020

Event Type  malfunction  

Event Description

It has been reported to philips that there was a burning smell from the x-ray tube cooling system.The department was evacuated.No harm has been reported to philips.Philips has started the investigation.

Manufacturer Narrative

Philips has investigated this complaint.According to the information collected, the hospital staff noticed a burning smell.The staff identified that the burning smell was coming from the multidiagnost eleva system that was located at the same department.The multidiagnost eleva system was switched off, the fire alarm activated and the department evacuated.There were no signs of smoke or flames.The system was not in clinical use at the time of the event.A philips engineer checked the system onsite and could not identify any burned components.The burning smell came from the tube cooling unit that had been replaced in the morning of the day of the event.The most probable cause was smoldering dust of the sound proofing insulating foam of the cover of the tube cooling unit.The insulating foam was removed.

• Brand Name: MULTIDIAGNOST ELEVA
• Type of Device: SYSTEM, X-RAY, ANGIOGRAPHIC
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.; veenpluis 4-6; best 5684 PC; NL 5684 PC
• MDR Report Key: 10873558
• MDR Text Key: 217689426
• Report Number: 3003768277-2020-01029
• Device Sequence Number: 1
• Product Code: IZI
• Combination Product (y/n): N
• PMA/PMN Number: K023441
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup

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?: Yes
• Device Operator: Health Professional
• Device Model Number: MULTIDIAGNOST ELEVA
• Device Catalogue Number: 708037
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 10/15/2020
• Initial Date Manufacturer Received: 11/13/2020
• Initial Date FDA Received: 11/20/2020
• Supplement Dates Manufacturer Received: 10/15/2020
• Supplement Dates FDA Received: 04/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1