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 Codes	Device Handling Problem (3265); Device Fell (4014)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/09/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Reference id: (b)(4).The digitaldiagnost c90 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.Analysis could not be performed as customer rejected the onsite visit for service and analysis.However preliminary assessment based on customer allegation concludes that the issue might have occurred as the detector might have been dropped by the user.Based on the information available, the cause of the problem couldn't be confirmed.Although, based off the assumption by the remote service engineer, it was concluded that the detector might have dropped.The device was returned to use with limitation as accepted by the customer.The investigation concludes that no further action is required at this time.
Event or Problem Description
It was reported the detector does not stays in place on wall stand bucky and that it might have dropped.The device was in clinical use and there was no patient or user harm.

• 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: 21033137
• Report Number: 3003768251-2024-000103
• Device Sequence Number: 4120020
• Product Code: MQB
• UDI-Device Identifier: 00884838090705
• UDI-Public: (01)00884838090705
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• 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): 12/30/2024

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: 12/09/2024
• Initial Report FDA Received Date: 12/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/12/2022
• 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