MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS DMC GMBH EASYDIAGNOST ELEVA DRF; SYSTEM, X-RAY, STATIONARY

Model Number	EASYDIAGNOST ELEVA DRF
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	05/19/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Reference id: (b)(4).Easydiagnost eleva is an xray system used for digital and conventional fluoroscopy and radiography.Philips received a complaint regarding an easydiagnost eleva r5x system where the footrest did not lock to the tabletop as intended.The device was not in clinical use at the time of the event.No patient or user injury occurred.The remote service engineer (rse) reproduced the issue with assistance from the customer.The customer attempted to move the footrest into multiple locking positions; however, the footrest did not lock properly.Investigation determined that replacement of the footrest was required.A replacement footrest was ordered and shipped to the customer site.The customer assumed responsibility for installation and servicing of the replacement part.The customer was advised to contact philips if additional support is required, at which time a new service order will be created.A good faith effort (gfe) was conducted with the rse.The rse confirmed that the issue was consistent with mechanical wear of the footrest locking mechanism over time.Based on the available information, the issue was attributed to normal wear of the footrest locking mechanism.A replacement footrest was ordered and shipped to the customer.
Event or Problem Description
It was reported that the footrest was not locking to tabletop for use.The device was outside clinical use and there was no patient or user harm.

• Brand Name: EASYDIAGNOST ELEVA DRF
• 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: 25514333
• Report Number: 3003768251-2026-100011
• Device Sequence Number: 18645209
• Product Code: KPR
• UDI-Device Identifier: 00884838074255
• UDI-Public: (01)00884838074255
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K031535
• 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): 06/16/2026

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: EASYDIAGNOST ELEVA DRF
• Device Catalogue Number: 706050
• 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: 05/19/2026
• Initial Report FDA Received Date: 06/16/2026
• 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