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

Model Number	RADIOGRAPHY 7300 C
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Codes	Pain (1994); Unspecified Musculoskeletal problem (4535)
Date of Event	11/18/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the system was not tracking properly and the tube was very difficult to move manually.This resulted in a shoulder injury to the user, and other staff members were unable to use the room.The device was not in clinical use at the time, and no patient harm occurred.
Additional Manufacturer Narrative
Reference id: (b)(4).The radiography 7300 c is a high-end digital radiography system equipped with a height-adjustable patient support table and a ceiling suspension system featuring a motorized, movable tube assembly with an integrated control handle.The system incorporates a philips x-ray generator and a pixium 4343rce flat-panel detector, forming the core of the radiography image chain.One key component is the ceiling suspension motorized (csm).The csm3 variant allows free longitudinal and transverse movement along the ceiling rails.Its telescoping column enables vertical motion of the tube assembly, collimator, and control grip, allowing precise positioning during radiographic procedures.Philips received a complaint on radiography 7300 c indicating that the system was not tracking properly and the tube was very difficult to move manually.This resulted in a shoulder injury to the user, and other staff members were unable to use the room.The device was not in clinical use at the time, and no patient harm occurred.The remote service engineer (rse) reported that no error messages were observed and that the system logs or philips remote service (prs) could not be accessed.The remote control was not functioning, resulting in loss of auto-tracking, although auto-tracking via the ceiling suspension (cs) button remained operational; the remote may not be charging or may require reconfiguration, as it was replaced in august.The system was described as very heavy to move in all directions, with locking issues above the table, while the wall stand operated normally.It was unclear whether the brakes were engaging and releasing correctly.Despite the stiffness, the system remained operational with a green ¿ready¿ status, though it felt significantly heavier than the site¿s other unit.A similar issue had occurred previously, during which the geometry positions and the remote were recalibrated.During the onsite visit, the field service engineer (fse) confirmed that the stiffness mainly affected vertical movement.Following technical support specialist (tss) guidance, the fse adjusted the counterweight spring unit to favor upward motion and submitted all measurements and information to the business innovation unit (biu) for further review, with a possible spring replacement planned for the new year.No parts were replaced, as the issue is related to the mechanical spring-tension mechanism.The system met the service specifications for the work performed and was returned to use.Based on the information available and the testing conducted, the cause of the reported problem was issue with the vertical movement.Investigation is in-progress.
Additional Manufacturer Narrative
Reference id: (b)(4).The radiography 7300 c is a high-end digital radiography system equipped with a height-adjustable patient support table and a ceiling suspension system featuring a motorized, movable tube assembly with an integrated control handle.The system incorporates a philips x-ray generator and a pixium 4343rce flat-panel detector, forming the core of the radiography image chain.One key component is the ceiling suspension motorized (csm).The csm3 variant allows free longitudinal and transverse movement along the ceiling rails.Its telescoping column enables vertical motion of the tube assembly, collimator, and control grip, allowing precise positioning during radiographic procedures.Philips received a complaint on radiography 7300 c indicating that the system was not tracking properly and the tube was very difficult to move manually.This resulted in a shoulder injury to the user, and other staff members were unable to use the room.The device was not in clinical use at the time, and no patient harm occurred.The remote service engineer (rse) reported that no error messages were observed and that the system logs or philips remote service (prs) could not be accessed.The remote control was not functioning, resulting in loss of auto-tracking, although auto-tracking via the ceiling suspension (cs) button remained operational; the remote may not be charging or may require reconfiguration, as it was replaced in august.The system was described as very heavy to move in all directions, with locking issues above the table, while the wall stand operated normally.It was unclear whether the brakes were engaging and releasing correctly.Despite the stiffness, the system remained operational with a green ¿ready¿ status, though it felt significantly heavier than the site¿s other unit.A similar issue had occurred previously, during which the geometry positions and the remote were recalibrated.During the onsite visit, the field service engineer (fse) confirmed that the stiffness mainly affected vertical movement.Following technical support specialist (tss) guidance, the fse adjusted the counterweight spring unit to favor upward motion and submitted all measurements and information to the business innovation unit (biu) for further review, with a possible spring replacement planned on this year.No parts were replaced, as the issue is related to the mechanical spring-tension mechanism.The system met the service specifications for the work performed and was returned to use.Based on recent impact assessments and review of complaint trends, philips decided to address this issue through a field correction using a field change order (fco).The decision was driven by an increased number of similar complaints associated with systems supplied by a new supplier.The system was confirmed to be within the scope of the planned fco, which includes inspection and replacement of weight compensating spring of the ceiling suspension and is planned for implementation at the site.This issue does not pose a regulatory compliance risk; however, in a worst-case scenario, product usability may be affected.Based on the information available and the testing conducted, the cause of the reported problem was issue with the cs vertical movement.No significant muscle or bone injury was reported.Currently, the user is taking anti-inflammatory medications and has been able to return to limited daily activities, with difficulty sleeping at night due to the pain.The device was restored to full functionality and returned to clinical use.Further inspection and follow-up actions will be completed as part of the planned fco implementation.Updated conclusion code grid.Updated evaluation results code grid.

• 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: 23802519
• Report Number: 3003768251-2025-000157
• Device Sequence Number: 15792857
• Product Code: MQB
• UDI-Device Identifier: 00884838116016
• UDI-Public: (01)00884838116016
• Combination Product (Y/N): N
• Initial Reporter Country: GI
• 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,Followup
• Report Date (Section B): 01/12/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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: 11/18/2025
• Supplement Date Received by Manufacturer: 01/06/2026
• Initial Report FDA Received Date: 12/15/2025
• Supplement Report FDA Received Date: 01/12/2026
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown