MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS DMC GMBH PROXIDIAGNOST N90; SYSTEM, X-RAY, STATIONARY

Model Number	PROXIDIAGNOST N90
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/27/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Proxidiagnost n90 is a multi-functional general r/f system.It is suitable for all routine radiography and fluoroscopy exams, including specialist areas like angiography or pediatric work, excluding mammography.This report is based on information provided by philips field service personnel and has been investigated by the philips complaint handling team.Philips received a complaint for the proxidiagnost n90 indicating that a piece of the footboard was missing, resulting in exposed internal parts and a potential safety concern.The issue was identified while the device was outside clinical use (during setup).There was no patient or user impact reported.The initial assessment by the field service engineer (fse) identified that a nut from the footrest side cover plate had come loose, leading to partial detachment of the footboard component and exposure of internal parts.As an immediate corrective action, the loose/missing hardware was addressed, and a replacement footrest assembly was ordered.The field engineer subsequently replaced the footrest assembly, followed by verification of proper installation and functionality.Post-service validation confirmed that the system was fully operational and met specifications, and the device was returned to service.Based on the available information, the most probable cause of the issue was loosening of the mounting nut over time due to normal wear and tear, resulting in detachment of the footboard component.The issue was resolved through hardware replacement, and no further issues were observed.The device was returned to use with full functionality.
Event or Problem Description
It was reported that the piece of the footboard was missing, resulting in exposed parts and a potential safety concern.The device was outside of use and there was no harm to the patient or user.

• Brand Name: PROXIDIAGNOST N90
• 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: 24956411
• Report Number: 3003768251-2026-100006
• Device Sequence Number: 12082301
• Product Code: JAA
• UDI-Device Identifier: 00884838085619
• UDI-Public: (01)00884838085619
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K173433
• 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
• Report Date (Section B): 04/22/2026

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: PROXIDIAGNOST N90
• Device Catalogue Number: 706100
• 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: 03/27/2026
• Initial Report FDA Received Date: 04/22/2026
• 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
• Patient Sex: Unknown