MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS DMC GMBH DIGITALDIAGNOST 4.1 FLEX / VALUE; SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER)

Model Number	DIGITALDIAGNOST 4.1 FLEX / VALUE
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	02/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Reference id: (b)(4).The digitaldiagnost 4.X is a stationary x-ray system for general radiographic purposes.As an option, a portable digital flat panel detector (model "skyplate") can be used for image capture.Philips received a complaint on digitaldiagnost 4.X indicating that images artifacts occurred due to bad cassette.The device was in clinical use and there was no harm to patient or user.The field service engineer (fse) performed analysis and concluded that the detector had been dropped, causing image artifacts.After attempting detector calibration, the detector failed the self-test, resulting in corrupted images.The fse replaced the detector and its protective cover, then performed detector calibration.The system passed the test and functioning properly.Based on the information available and the testing conducted, the cause of the reported problem was detector drop.The reported problem was confirmed by the customer.Thus, it is concluded that the detector was dropped by accident (use error).
Event or Problem Description
It was reported that the images artifacts occurred due to bad cassette.The device was in clinical use and there was no patient or user harm.Additional information received that the detector was dropped.

• Brand Name: DIGITALDIAGNOST 4.1 FLEX / VALUE
• 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: 21569576
• Report Number: 3003768251-2025-000030
• Device Sequence Number: 8347013
• Product Code: MQB
• UDI-Device Identifier: 00884838074514
• UDI-Public: (01)00884838074514
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K170113
• 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): 03/11/2025

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: DIGITALDIAGNOST 4.1 FLEX / VALUE
• Device Catalogue Number: 712032
• 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: 02/17/2025
• Initial Report FDA Received Date: 03/11/2025
• 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