MAUDE Adverse Event Report: Philips Medical Systems DMC GmbH CombiDiagnost R90; table, radiologic

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	09/03/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the detachable foot table board was broken and would not attach to the table due to physical damage.The device was not in clinical use, and there was no patient or user harm.
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 detachable foot table board was broken and would not attach to the table due to physical damage.The device was not in clinical use, and there was no patient or user harm.The remote service engineer (rse) performed a visual inspection of the device with assistance from the customer and confirmed that the detachable foot table board was cracked on the left side and would not lock onto the table.A replacement footrest was sent per the customer¿s request.The field service engineer (fse) visited the site, reviewed all error logs to confirm that no errors were present, and verified that system functionality was not impacted.The fse then performed functional testing of the system table geometry and found that the footrest would not lock into position correctly.The footrest was replaced, and the fse repeated functional testing of the system table geometry movements and positions.The issue did not reproduce.A good faith effort (gfe) was raised to the fse, and it was confirmed that the issue occurred due to user error.Based on the available information, the cause of the reported issue was identified as use error.

• Brand Name: CombiDiagnost R90
• Common Device Name: table, radiologic
• 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: 50934069
• Report Number: 3003768251-2026-100040
• Device Sequence Number: 13152510
• Product Code: JAA
• UDI-Device Identifier: 00884838101456
• UDI-Public: (01)00884838101456
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 09/29/2026

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: CombiDiagnost R90
• Device Catalogue Number: 709031
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/03/2026
• Initial Report FDA Received Date: 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/06/2023
• 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