MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS DMC GMBH DIGITALDIAGNOST C90 HIGHPERFORMANCE; SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER)

Model Number	DIGITALDIAGNOST C90
Medical Device Problem Codes	Circuit Failure (1089); Smoking (1585); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/19/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the system down due to ub board burnt.The device was not in clinical use and there was no patient or user harm.
Additional Manufacturer Narrative
Reference id: (b)(4).The digitaldiagnost c90 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 c90 indicating that the system down due to ub board burnt.The device was not in clinical use and there was no patient or user harm.The field service engineer (fse) visited onsite and confirmed that the mov on the ub board was burned, causing thermal and electrical damage to nearby components and connectors.The damage is consistent with a sudden high-voltage surge.Site checks identified unstable hospital earthing, with earth voltage fluctuating between approximately 3.5 v and up to 230 v.The customer reported the burning occurred around 12:00 pm while the system was in standby, and a loud humming noise was observed from the mcb in the power distribution box.The issue was resolved by replacing the affected hose/cable assembly and damaged components.System testing, configuration, full calibration, safety tests, and test exposures were successfully completed, and the system is now operating within manufacturer specifications.A power monitor has been installed to track voltage stability following repair of the site earthing.Investigation in-progress and root cause not yet determined.
Additional Manufacturer Narrative
Reference id: (b)(4).The digitaldiagnost c90 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 c90 indicating that the system down due to ub board burnt.The device was not in clinical use and there was no patient or user harm.The field service engineer (fse) performed an onsite evaluation and confirmed that the ub board failure was caused by an external high-voltage surge associated with severe grounding instability at the site.The surge resulted in failure of the metal oxide varistor (mov) on the ub board, leading to thermal and electrical damage to adjacent components and connectors.The damage pattern was consistent with a sudden high-voltage event.Smoke was observed, which activated the facility fire alarm; however, the customer confirmed that no visible flames were present.Site assessment identified unstable hospital earthing conditions, with earth voltage fluctuating approximately between 3.5 v and 230 v.The customer reported that the burning event occurred around 12:00 pm while the system was in standby mode.A loud humming noise was also noted from the miniature circuit breaker (mcb) in the power distribution box.Corrective actions included replacement of the affected hose/cable assembly and damaged components.Following replacement, full system testing, configuration, calibration, safety verification, and test exposures were successfully completed.The system was confirmed to be operating within manufacturer specifications.Additionally, a power monitoring device was installed to track voltage stability after corrective action on the site earthing.Technical investigation outcome (r&d assessment): based on review of images, videos and details provided by the fse, the r&d team concluded that the failure mechanism was consistent with mov degradation and failure under abnormal electrical conditions.The following contributing factors were identified: 1.Polarity and miswiring incidents occasional line¿neutral interchange or reverse polarity during maintenance or system startup may result in unintended conduction, accelerating mov degradation and reducing service life.2.Electrical stress mechanisms.Sustained overvoltage: prolonged exposure to voltages exceeding the mov rating can cause overheating and breakdown.Excessive surge currents: high-energy transients (e.G., lightning or switching surges) may exceed the mov¿s energy rating, resulting in catastrophic failure.Repeated minor surges: frequent small transients can progressively degrade mov material properties until failure occurs.Solution / recommendations: to enhance protection of the ub board, installation of an upstream protection circuit prior to the ub board is recommended.This may include use of a surge arrester and main transformer configuration where applicable.In hospital or field environments, appropriate protective devices must be installed to safeguard equipment against overcurrent and overvoltage conditions.These may include: mcb - for overcurrent protection.Surge protection device (spd) - for protection against transient voltage surges surge arrester - for diversion of high-energy surge currents to ground installation and maintenance of such site-level electrical protection measures fall under hospital infrastructure responsibility.This requirement and observation were communicated to the field service engineer (fse).As sufficient evidence, including images and videos, was available to support the investigation and the root cause has been determined, r&d team confirmed that the return of the defective part for further analysis is not required.Based on the available information and technical analysis, the reported issue was caused by mov failure due to a high-voltage surge associated with unstable site grounding conditions.No injuries were reported.The event was limited to component damage (burned ub board).The issue has been resolved through component replacement and system verification testing.The system is confirmed to be operating within manufacturer specifications.Updated (device) problem code grid.Updated evaluation results code grid.Updated conclusion code grid.

• Brand Name: DIGITALDIAGNOST C90 HIGHPERFORMANCE
• 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 ; roentgenstrasse 24; hamburg 22335 ; GM 22335
• MDR Report Key: 23849379
• Report Number: 3003768251-2025-000162
• Device Sequence Number: 13251531
• Product Code: MQB
• UDI-Device Identifier: 00884838090699
• UDI-Public: (01)00884838090699
• Combination Product (Y/N): N
• Initial Reporter Country: SA
• PMA/510(K) Number: K182973
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/24/2026

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 C90
• Device Catalogue Number: 712034
• 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: 11/19/2025
• Supplement Date Received by Manufacturer: 02/18/2026
• Initial Report FDA Received Date: 12/19/2025
• Supplement Report FDA Received Date: 02/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/11/2024
• 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