MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS DMC GMBH DIGITALDIAGNOST 4.1 HIGH PERFORMANCE; SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER)

Model Number	DIGITALDIAGNOST 4.1 HIGH PERFORMANCE
Medical Device Problem Code	Fire (1245)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/26/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Reference id: (b)(4).The digitaldiagnost 4.X is a stationary x-ray system for general radiographic purposes.The ceiling suspension module (csm) manages and supports the mechanical movement and positioning of the x-ray tube along the ceiling-mounted rails.Philips received a complaint on digitaldiagnost 4.X indicating that the machine was not switching on while tries to diagnosis controller board gets short and starts fire.The device was outside of clinical use and there was no patient or user harm.Field service engineer (fse) visited onsite to analysis the reported issue and determined that the system was not switching on.Upon inspection, the fse identified a burnt controller board and damaged cables connected to the ceiling suspension module (csm) field.No fire alarm was triggered, although the customer used a fire extinguisher as a precaution.There was no reported power surge at the hospital.Requested for defective part return for further analysis.Root cause was not identified as of now.Investigation is in-progress.
Event or Problem Description
It was reported that the machine is not switching on while tries to diagnosis controller board gets short and starts fire.The device was outside of clinical use and there was no patient or user harm.
Additional Manufacturer Narrative
Reference id: (b)(4).The digitaldiagnost 4.X is a stationary x-ray system for general radiographic purposes.As an option, a portable digital flat panel detector (model "skyplate") can be used for image capture.Philips received a complaint on digitaldiagnost 4.X indicating that machine is not switching on while tries to diagnosis ceiling-mounted tube (cmt) controller board gets short and starts fire.The device was outside of clinical use and there was no harm to patient or user.The field service engineer (fse) conducted a detailed analysis and found that the system was not powering on due to a short circuit in the cmt controller board, which had caught fire as a result of water leakage from the rooftop.A fire extinguisher was used to extinguish the fire; however, no fire alarm was triggered during the incident.Upon inspection, it was identified that the user application (ua) board was completely damaged and non-functional.After replacing the ua board, the system powered on but entered a restricted operating mode.Further evaluation revealed a software malfunction¿exposure functionality was disabled in user mode, although it operated correctly in service mode, confirming a software-related issue.To resolve this, the ua field of the ceiling suspension module (csm) board was replaced, and the system software was reloaded.Following these actions, the system was restored to full functionality and successfully handed over for clinical use.Based on the available information and testing performed, the root cause of the reported issue was identified as water leakage from the ceiling rooftop¿an environmental condition that led to the problem.The field service engineer (fse) resolved the issue by sealing the leakage path and redirecting the water flow away from the machine area.The resolution and root cause have been confirmed by the customer.

• Brand Name: DIGITALDIAGNOST 4.1 HIGH PERFORMANCE
• Common Device Name: SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER)
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS DMC GMBH; roentgenstrasse 24; hamburg 22335 ; GM 22335
• Manufacturer (Section G): PHILIPS MEDICAL SYSTEMS DMC GMBH; roentgenstrasse 24; hamburg 22335 ; GM 22335
• Manufacturer Contact: dusty leppert ; 100 park avenue, suite 300; orange village, OH 44122
• MDR Report Key: 22082479
• Report Number: 3003768251-2025-000076
• Device Sequence Number: 18114142
• Product Code: MQB
• UDI-Device Identifier: 00884838065321
• UDI-Public: (01)00884838065321
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K141736
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/03/2025

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
• Operator of Device: Health Professional
• Device Model Number: DIGITALDIAGNOST 4.1 HIGH PERFORMANCE
• Device Catalogue Number: 712031
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/26/2025
• Supplement Date Received by Manufacturer: 06/06/2025
• Initial Report FDA Received Date: 05/25/2025
• Supplement Report FDA Received Date: 07/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown