MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS DMC GMBH COMBIDIAGNOST R90; SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER)

Model Number	COMBIDIAGNOST R90
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	Unspecified Musculoskeletal problem (4535)
Date of Event	11/07/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the ceiling suspension (cs) was difficult to move, and as a result, the user experienced a back injury.The device was in clinical use.
Additional Manufacturer Narrative
Reference id: (b)(4).The combidiagnost is a remote-controlled system, which supports general radiography and fluoroscopy imaging.As an option, a portable digital flat panel detector (model "sky plate") can be used for image capture.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 on combidiagnost r90 indicating that ceiling suspension hard to move.The field service engineer (fse) performed analysis and concluded that measure the force that requires to move ceiling suspension.The results showed that vertical movement requires 30 n downward and 65 n upward, longitudinal movement requires 5 n to the left and 10 n to the right, while lateral movement requires 10 n forward and 9 n backward.Investigation is in-progress.
Additional Manufacturer Narrative
Reference id: (b)(4).The combidiagnost r90 is a remote-controlled system designed to support general radiography and fluoroscopy imaging.As an option, a portable digital flat panel detector (skyplate) can be used for image acquisition.Philips received a complaint reporting that the ceiling suspension was hard to move.During use, the operator experienced back pain while moving the ceiling suspension.The user required physiotherapy for two weeks and was unable to return to work or normal activities for approximately three weeks.A field service engineer (fse) visited the site and measured the force required to move the ceiling suspension.The measurements indicated that vertical movement required 30 n downward and 65 n upward, longitudinal movement required 5 n to the left and 10 n to the right, and lateral movement required 10 n forward and 9 n backward.All measured values were within the specified limits.No system log files were available for the date of the reported event; therefore, log file analysis could not be performed.Based on recent impact assessments and review of complaint trends, philips decided to address this issue through a field correction using a field change order (fco).The decision was driven by an increased number of similar complaints associated with systems supplied by a new supplier.The system was confirmed to be within the scope of the planned fco, which includes inspection and minor adjustments of the ceiling suspension and is planned for implementation at the site.This issue does not pose a regulatory compliance risk; however, in a worst-case scenario, product usability may be affected.New information indicated that user¿s preexisting back injury conditions were unknown.There was no significant muscle or bone damage; imaging was not required, and the injury was getting better.The user could not return to work or regular activities for three weeks.Physical therapy sessions are scheduled for twice a week.Multiple attempts were made to confirm the exact sequence of events leading to the reported injury; however, no confirmation was received from the injured user.As a precautionary measure and based on the possibility that vertical movement stiffness could have contributed to the injury, the fse proceeded with planning the fco implementation to ensure appropriate inspection and follow-up.No significant muscle or bone injury was reported.The user¿s condition improved with physiotherapy, and recovery was ongoing at the time of reporting.The device was restored to full functionality and returned to clinical use.Further inspection and follow-up actions will be completed as part of the planned fco implementation.Updated evaluation results code grid & conclusion grid code.

• Brand Name: COMBIDIAGNOST R90
• 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: 23800305
• Report Number: 3003768251-2025-000156
• Device Sequence Number: 12695755
• Product Code: MQB
• UDI-Device Identifier: 00884838101456
• UDI-Public: (01)00884838101456
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K141736
• 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): 01/12/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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: 11/07/2025
• Supplement Date Received by Manufacturer: 01/06/2026
• Initial Report FDA Received Date: 12/15/2025
• Supplement Report FDA Received Date: 01/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/28/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown