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	07/17/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Reference id: pr (b)(4).The digitaldiagnost r4.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.The local field service engineer (fse) performed analysis which concluded that the large detector was damaged and caused grey images.Gain and pixel calibration was performed but the image qualities were not okay.The detector was replaced in accordance with manufacturer specifications.Protective cover was attached and detector successfully calibrated.The device was replaced and after calibration, returned for clinical use with full functionality.
Event or Problem Description
It was reported that detector was damaged after it was dropped.The device was not in clinical use and there was no harm to patient or user.
Additional Manufacturer Narrative
Reference id: (b)(4) following are the corrections made pertaining to emdr report number 3003768251-2024-00055 (5067762): 1.Contact office: changed from (b)(6), 2.Date received by mfg: changed from "blank" to "07/17/2024.".

• 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: 19970890
• Report Number: 3003768251-2024-00055
• Device Sequence Number: 21073393
• Product Code: MQB
• UDI-Device Identifier: 00884838074514
• UDI-Public: 00884838074514
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• 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): 02/03/2025

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: 07/17/2024
• Supplement Date Received by Manufacturer: 07/17/2024
• Initial Report FDA Received Date: 08/13/2024
• Supplement Report FDA Received Date: 02/03/2025
• 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