MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS DMC GMBH RADIOGRAPHY 7300 C; SYSTEM, X-RAY, STATIONARY

Model Number	RADIOGRAPHY 7300 C
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	09/30/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that third detector does not bind.The device was in clinical use and there was no patient or user harm.
Additional Manufacturer Narrative
Reference id: (b)(4).Radiography 7300 c is a high-end digital system featuring a height-adjustable patient support table and a ceiling suspension with a movable tube and control handle.It includes a philips x-ray generator and a pixium (b)(6) flat panel rad detector, forming the radiography image chain.The system also offers a portable wireless detector option, the skyplate family, for flexible exposures.Philips received a complaint on radiography 7300 c indicating that the third detector does not bind.The device was in clinical use and there was no harm to patient or user.The field service engineer (fse) performed an analysis and concluded that the detector had been dropped, an image was captured to assess any damage resulting from the fall.During an attempt to x-ray a pen, the image showed two large stripes, making it difficult to view the actual object clearly.After that, the detector¿s status light flashed red, the leds briefly turned red and then switched off, and the detector failed to connect to the system.The fse tried replacing the battery and re-linking the detector, but the issue persisted.The connector unit was also replaced, but the detector still did not connect to the equipment.As a result, the fse concluded that the detector needed to be replaced, and a replacement quotation had been sent to the customer 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: RADIOGRAPHY 7300 C
• Common Device Name: SYSTEM, X-RAY, STATIONARY
• 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: 23276991
• Report Number: 3003768251-2025-000123
• Device Sequence Number: 17522897
• Product Code: KPR
• UDI-Device Identifier: 00884838116016
• UDI-Public: (01)00884838116016
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K233662
• 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): 10/13/2025

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: RADIOGRAPHY 7300 C
• Device Catalogue Number: 712037
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/30/2025
• Initial Report FDA Received Date: 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/11/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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