MAUDE Adverse Event Report: Philips Medical Systems DMC GmbH DigitalDiagnost C90 Flex/Value/Chest/Emergency Room; solid state X-ray imager (flat panel/digital imager)

Model Number	DigitalDiagnost C90
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	Muscle/Tendon Damage (4532)
Date of Event	08/26/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the comfort positioning feature was not performing as intended while the device was in clinical use.A good faith effort (gfe) was initiated which confirmed that only one user was affected by the reported issue.The user, sustained a minor strain to their right (dominant) shoulder and was assessed by their general practitioner, including an ultrasound scan.No further treatment or medical intervention was required.The user has fully recovered, with no expected impact on function or range of motion.
Additional Manufacturer Narrative
Reference id- (b)(4).The digitaldiagnost c90 is a stationary x-ray system for general radiographic purposes.The ceiling suspension (cs) can be freely moved longitudinally and transversely; the telescoping column allows the tube assembly, collimator and control grip to move vertically up and down.The movement via remote control is possible only with a fully motorized ceiling suspension (csm comfort position).Philips received a complaint on digitaldiagnost c90 indicating that the comfort positioning feature was not performing as intended while the device was in clinical use.A good faith effort (gfe) was initiated which confirmed that only one user was affected by the reported issue.The user, sustained a minor strain to their right (dominant) shoulder and was assessed by their general practitioner, including an ultrasound scan.No further treatment or medical intervention was required.The user has fully recovered, with no expected impact on function or range of motion.Investigation in-progress.

• Brand Name: DigitalDiagnost C90 Flex/Value/Chest/Emergency Room
• Common Device Name: solid state X-ray imager (flat panel/digital imager)
• 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: 50785869
• Report Number: 3003768251-2026-100033
• Device Sequence Number: 9570919
• Product Code: MQB
• UDI-Device Identifier: 00884838090705
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K182973
• 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
• Report Date (Section B): 09/16/2026

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: DigitalDiagnost C90
• Device Catalogue Number: 712035
• 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: 08/26/2026
• Initial Report FDA Received Date: 09/16/2026
• 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