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 Codes	Device Handling Problem (3265); Device Fell (4014)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/15/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Event description: it was reported that the skyplate was dropped and is not working; no image.The device was not in 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 on the skyplate was dropped and is not working - no image.The device was not in clinical use and there was no patient or user harm.The remote service engineer (rse) performed analysis and concluded that a detector had been dropped, resulting in a loss of full communication with the system and produce blank images.The rse provided remote assistance to guide the customer through skyplate sharing instructions as a temporary solution, in case a detector from another system was available.During testing via philips service console (psc) tools, it was identified that certain diagnostics could not be completed due to an integrated service tool (ist) access issue; appropriate contact details were provided to the customer for ist correction.Troubleshooting options were discussed, and the customer confirmed that two quotation requests were raised ¿ one for an onsite service visit and another for outright skyplate replacement.The customer agreed to decide the preferred option.Subsequently, a new servicemax case was opened for skyplate replacement.The field service engineer (fse) visited the site, gathered all required skyplate exchange information was gathered, and a new detector was installed and calibrated successfully, restoring full communication and system functionality.Based on the information available and the testing conducted, the cause of the reported problem was detector drop.The reported problem was confirmed by the customer.Thus, it is concluded that the detector was dropped by accident (use error).

• 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: 23404200
• Report Number: 3003768251-2025-000127
• Device Sequence Number: 17375344
• Product Code: MQB
• UDI-Device Identifier: 00884838065321
• UDI-Public: (01)00884838065321
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/28/2025

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: 10/15/2025
• Initial Report FDA Received Date: 10/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/13/2023
• 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