MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS DMC GMBH RAIDOGRAPHY 7000 M; SYSTEM, X-RAY, MOBILE

Model Number	RADIOGRAPHY 7000 M
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	03/06/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Reference id: (b)(4).The radiography 7000 m is a motorized mobile x-ray system designed for diagnostic imaging of both adult and pediatric patients who cannot be transferred to a stationary x-ray system.It supports imaging of various body parts, including the skull, chest, spine, shoulders, pelvis, extremities, and abdomen, in multiple positions such as sitting, standing, and lying (prone or supine).The system utilizes integrated wireless flat panel detectors (large and small sizes) for digital imaging in mobile settings and offers a backup option with cr or traditional film cassettes.Philips received an automatic complaint on the radiography 7000m indicating that the detector was not linking to the system and there was an average impact on the portable detector.No harm was reported.The field service engineer (fse) performed analysis and concluded that the detector was not linking to the system and there was an average impact on the portable detector.Upon follow up, additional information received confirming that the detector was dropped by the user.No sign of tear or wear on the detector itself.Detector calibration performed, and it's passed.System is fully functional.Based on the information available and the testing conducted, the cause of the reported problem was the detector drop.The reported problem was confirmed.No details were provided about the circumstances when the detector fell down.As the customer did not make other claims, it is concluded that the detector was dropped by accident (use error).
Event or Problem Description
It was reported that the detector was not linking to the system and there was an average impact on the portable detector.No harm was reported.Upon follow up, additional information received confirming that the detector was dropped.

• Brand Name: RAIDOGRAPHY 7000 M
• Common Device Name: SYSTEM, X-RAY, MOBILE
• 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: 21632692
• Report Number: 3003768251-2025-000036
• Device Sequence Number: 9276693
• Product Code: IZL
• UDI-Device Identifier: 00884838115521
• UDI-Public: (01)00884838115521
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K233678
• 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): 03/18/2025

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 7000 M
• Device Catalogue Number: 712010
• 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: 03/06/2025
• Initial Report FDA Received Date: 03/18/2025
• 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