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	02/26/2025
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.Note: it is not suitable for mammography applications.Philips received a complaint on radiography 7000 m indicating that the heavy mechanical shock was recorded on the detector.The device was not in clinical use and there was no harm to patient or user.The filed service engineer (fse) performed analysis and concluded that the detector had been dropped.Mechanical shocks were recorded in the detector's shock log.Calibration was performed to the detector, and both the system and detector were found to be functioning properly.System returned to clinical use with full 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).
Event or Problem Description
It was reported that the heavy mechanical shock was recorded on the detector.The device was not in clinical use and there was no harm to patient or user.Additional information received 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: 21606386
• Report Number: 3003768251-2025-000035
• Device Sequence Number: 8896042
• Product Code: IZL
• UDI-Device Identifier: 00884838115521
• UDI-Public: (01)00884838115521
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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): 03/14/2025

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: 02/26/2025
• Initial Report FDA Received Date: 03/14/2025
• 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