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

Model Number MULTIDIAGNOST ELEVA

Device Problem Smoking (1585)

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

Event Date 06/09/2023

Event Type  malfunction  

Event Description

It was reported to philips that the live screen monitor from the ceiling monitor suspension (cms) in the examination room started to emit smoke.The system was not in clinical use.No user or patient harm has been reported.Philips has started an investigation regarding the reported issue.

Manufacturer Narrative

Philips has investigated this complaint.The philips remote service engineer (rse) confirmed that the ceiling monitor suspension (cms) in the examination room was emitting smoke.Upon functional analysis the problem was found inside the screen which caused the screen to emit smoke.The rse suggested to swap the live screen with the reference screen in the examination room.The customer has swapped the live screen with the reference screen and the system was returned to use in good working order.The codes were updated based on the investigation outcome.Evaluation method code was corrected.

• Brand Name: MULTIDIAGNOST ELEVA
• Type of Device: SYSTEM, X-RAY, ANGIOGRAPHIC
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.; veenpluis 6; best 5684 PC; NL 5684 PC
• Manufacturer (Section G): PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.; veenpluis 6; best 5684 PC; NL 5684 PC
• Manufacturer Contact: srinivas nss ; 3000 minuteman rd; andover, MA 01810 ; 6172455900
• MDR Report Key: 17136398
• MDR Text Key: 317271404
• Report Number: 3003768277-2023-03654
• Device Sequence Number: 1
• Product Code: IZI
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K023441
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• 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: 708034
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/09/2023
• Initial Date FDA Received: 06/15/2023
• Supplement Dates Manufacturer Received: 08/28/2023
• Supplement Dates FDA Received: 09/05/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2007
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1