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

Model Number	RADIOGRAPHY 7000 M
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/31/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that while reversing the system into the elevator, a release of the handle occurred to press the button, causing backward movement of about a foot with a rightward turn.No contact with the handle was maintained during that time.The device use is unknown and there was no harm to patient or user.
Additional Manufacturer Narrative
The complaint is still under investigation.
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 system drove backwards on its own.The filed service engineer (fse) performed analysis and concluded that the symptom could intermittently be reproduced when driving slowly in reverse and also found to be reproducible with all systems so isn't a something wrong with this particular system.To address this issue, a long-term solution will be implemented through a field change order (fco) at a later date.In the short term, technicians and users have been instructed to come to a complete stop before releasing the handlebar when driving.The system has now been returned to clinical use.A health hazard evaluation and determination (hhed) has been initiated to address this issue.Outcome of hhed: technical investigation: the radiography 7000 m has a drive handle that is used to disengage the brake while moving the unit.This movement must stop as soon as the drive handle is released by the user.However, a latest scenario shows that when the system is being pulled back, it does not immediately stop even after releasing the drive handle and moves very short distance before stopping.It was confirmed that when the user reverses the system very slowly and releases the handle before bringing the system to a full stop, the system continues to move backward for a very short distance at very low speed of approximately 1.6 km/h before coming to a stop.The impact force at slow speed would be 20.9n.The behavior is not seen in forward motion.The wheel moves backward for a distance of approximately 6¿8 cm over 1.5 seconds.The system maintains sufficient ground clearance and rear distance, preventing any risk of running over or crushing a foot.This is not a product misidentified issue.As per investigation from r&d that the issues observed in the field are a result of improper application of the brakes.After instructing the users on the driving behavior to ensure not to release the drive handle until the system has come to complete stop like instructed in the instruction for use (ifu), the fse confirmed that the issue had not been reported.Also, no new case has been reported for this similar issue.In addition, proper handling of the device has been elaborated in the ifu of radiography 7000m.Based on the information available and the testing conducted, the cause of the reported problem was user error.The reported problem was confirmed based on the technical investigation and hhed process as use error.Risk estimation revealed no unacceptable risk.The issue is further monitored and trended.The event was originally reported to the authorities as not enough information was available to make a definite reportability decision.Since that time, additional information was received which revealed that the event does not meet the criteria for reporting.

• 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: 21917393
• Report Number: 3003768251-2025-000063
• Device Sequence Number: 13033196
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/19/2025

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: 03/31/2025
• Supplement Date Received by Manufacturer: 06/12/2025
• Initial Report FDA Received Date: 04/28/2025
• Supplement Report FDA Received Date: 06/19/2025
• 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