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	Device Handling Problem (3265); Device Fell (4014)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/26/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the detector dropped and not working.The device was in clinical use and there was no patient or user harm.
Additional Manufacturer Narrative
Reference id: (b)(4).The digital diagnost 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.This report is based on information provided by philips field service personnel and has been investigated by the philips complaint handling team.Philips received a complaint on digitaldiagnost c90 indicating that the detector dropped and not working.The device was in use and there was no harm to patients or user.The field service engineer (fse) performed analysis and concluded that the detector has been dropped, resulting in large image artifacts covering most of the detector area.There were heavy shocks registered in the detector shock log.Attempts to correct the issue via pixel calibration were unsuccessful.Consequently, the detector was deemed non-functional and required replacement.A new skyplate detector was installed, properly connected, and configured.Calibration was successfully performed.A visual inspection and functional checks were completed, confirming the system is operating within manufacturer specifications.The unit was returned to clinical use with full functionality.Based on the information available and the testing conducted, the cause of the reported problem was detector dropped and resulted in large image artifacts.The reported problem was confirmed by the customer.Thus, it is concluded that the detector was dropped by accident (use error).

• 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 ; 100 park avenue, suite 300; orange village, OH 44122
• MDR Report Key: 22553077
• Report Number: 3003768251-2025-000094
• Device Sequence Number: 9647471
• Product Code: MQB
• UDI-Device Identifier: 00884838090699
• UDI-Public: (01)00884838090699
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/21/2025

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 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: 06/26/2025
• Initial Report FDA Received Date: 07/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/19/2021
• 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