MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS DMC GMBH PRECISION CRF; IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM

Model Number	PRECISION CRF
Medical Device Problem Codes	Device Handling Problem (3265); Device Fell (4014)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/09/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the system was not exposing, the green light did not appear, having to rotter for long periods.The use of device was unknown and there was no patient or user harm.
Additional Manufacturer Narrative
Reference id: (b)(4).Proxidiagnost n90/ precision crf is a multi-functional general r/f system.It is suitable for all routine radiography and fluoroscopy exams, including specialist areas like angiography or pediatric work, excluding mammography.Philips received a complaint on proxidiagnost n90 indicating that the system was not exposing, the green light did not appear, having to rotter for long periods of time.The use of device was unknown and there was no harm to patient or user.The field service engineer (fse) performed analysis and concluded that the system was not exposing due to the detector being dropped.Fse replaced the damaged detector with a new unit and performed a calibration.The system was then verified for proper functionality and returned to clinical use.Based on the information available and the testing conducted, the cause of the reported problem was damage to the skyplate.The reported problem was confirmed by the customer.Thus, it is concluded that the detector was dropped by accident (use error).

• Brand Name: PRECISION CRF
• Common Device Name: IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM
• 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: 23435265
• Report Number: 3003768251-2025-000131
• Device Sequence Number: 8552592
• Product Code: JAA
• UDI-Device Identifier: 00884838110588
• UDI-Public: (01)00884838110588
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K233945
• 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): 10/31/2025

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: PRECISION CRF
• Device Catalogue Number: 706400
• 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: 10/03/2025
• Initial Report FDA Received Date: 10/31/2025
• 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