MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS DMC GMBH COMBIDIAGNOST R90; SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE-INTENSIFIED

Model Number	COMBIDIAGNOST R90
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	03/12/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the footstep where the patient can stand on it has come off / seems to be broken.The device was in clinical use and there was no patient or user harm.
Additional Manufacturer Narrative
Ref id: (b)(4).The investigation still in-progress.
Additional Manufacturer Narrative
Reference id (b)(4).Combidiagnost r90 is an x-ray unit for nearby controlled digital and conventional fluoroscopy and radiography.When the footrest is not locked into place on both sides, it can slide off the table when the table is tilted up.Philips received a complaint on combidiagnost r90 indicating that the footboard on the table come off / seems to be broken.The device was in use and there was no harm to the patient or user.Field service engineer (fse) performed analysis and concluded that plastic part (teflon tape) in the guide of the kick was loose, causing it no longer holds reliably on the table.The footrest was fixed.The device was checked and found to be functioning properly.Based on the information available and the testing conducted, the cause of the reported problem was wear and tear.The reported problem was confirmed by the customer.

• Brand Name: COMBIDIAGNOST R90
• Common Device Name: SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE-INTENSIFIED
• 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: 21733383
• Report Number: 3003768251-2025-000045
• Device Sequence Number: 20991456
• Product Code: JAA
• UDI-Device Identifier: 00884838101456
• UDI-Public: (01)00884838101456
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K203087
• 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): 04/16/2025

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: COMBIDIAGNOST R90
• Device Catalogue Number: 709031
• 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: 03/12/2025
• Supplement Date Received by Manufacturer: 03/12/2025
• Initial Report FDA Received Date: 03/31/2025
• Supplement Report FDA Received Date: 04/16/2025
• 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