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	03/04/2025
Type of Reportable Event	Malfunction
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 4343rce 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 skyplate fell and has artifacts in image.The device was in clinical use and there was no harm to patient or user.The field service engineer (fse) performed analysis and concluded that the detector had been dropped, resulting in image artifacts.Attempts to calibrate the detector were unsuccessful.The detector needs to be replaced.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).
Event or Problem Description
It was reported that the skyplate fell and has artifacts in image.The device was in clinical use and there was no harm to patient or user.Additional information received that the detector was dropped by the customer.

• 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: 21570761
• Report Number: 3003768251-2025-000031
• Device Sequence Number: 8272688
• Product Code: KPR
• UDI-Device Identifier: 00884838116016
• UDI-Public: (01)00884838116016
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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): 03/11/2025

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): Thirty-Day
• Initial Date Received by Manufacturer: 03/04/2025
• Initial Report FDA Received Date: 03/11/2025
• 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