MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS DMC GMBH PROXIDIAGNOST N90 REL 1.1; INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM

Model Number	PROXIDIAGNOST N90 REL 1.1
Medical Device Problem Codes	Use of Device Problem (1670); Device Fell (4014)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/23/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there was damage to the detector (skyplate) with artifacts.It was unable to connect portable skyplate detector to the system.There was no harm to patient or user.
Additional Manufacturer Narrative
Reference id:(b)(4).Proxidiagnost is an x-ray unit for nearby controlled digital and conventional fluoroscopy and radiography.As an option, a portable digital flat panel detector (model "skyplate") can be used for image capture.Philips field service engineer performed on site analysis which concluded that the detector was damaged due to user dropping it on the corner of the table top.Calibration was successfully performed for the detector however the images still showed artifacts due to the damage.The device was replaced with new detector and is returned to use with full functionality.
Additional Manufacturer Narrative
Reference id: (b)(4).Following are the corrections made pertaining to emdr report number 3003768251-2024-00037 (4880980): 1.Contact office: changed from "(b)(4)" to "(b)(4)." 2.Date received by mfg: changed from "blank" to "05/23/2024.".

• Brand Name: PROXIDIAGNOST N90 REL 1.1
• Common Device Name: INTERVENTIONAL 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: 19583462
• Report Number: 3003768251-2024-00037
• Device Sequence Number: 3340615
• Product Code: JAA
• UDI-Device Identifier: 00884838103221
• UDI-Public: 00884838103221
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K173433
• 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,Followup
• Report Date (Section B): 10/24/2024

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: PROXIDIAGNOST N90 REL 1.1
• Device Catalogue Number: 706110
• 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: Not provided
• Supplement Date Received by Manufacturer: 05/23/2024
• Initial Report FDA Received Date: 06/21/2024
• Supplement Report FDA Received Date: 10/24/2024
• 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