MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS DMC GMBH PROXIDIAGNOST N90; SYSTEM, X-RAY, STATIONARY

Model Number	706100
Medical Device Problem Code	Misassembled During Installation (4049)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Ref.Id: 2367893 the investigation is still ongoing on this event.When the investigation is completed a follow-up report will be sent to the fda.
Event or Problem Description
During installation of the system, it was found that a couple of the rail connection blocks were mis-aligned in the ceiling unistrut.No injury reported.
Additional Manufacturer Narrative
Ref.Id: (b)(4).The proxidiagnost system is a stationary nearby-controlled system supports general radiography and fluoroscopy imaging.The systems consists of several components that can be combined in various configurations to form x-ray systems.One component is the celling suspension to which the x-ray tube with the collimator is attached.To get the ceiling suspension connected to the ceiling, anchor rails must be mounted into the ceiling, these anchor rails can be of different types e.G.¿unistrut¿.During completion of installation it was discovered a misalignment of fixing blocks and unistrut anchor rails.Some of the fixing blocks are not properly seated in the ¿unistrut¿ anchor rails by a 3rd party.A capa investigation revealed that more than this system were affected.The problem on the affected systems was resolved by an field corrective action (fco70600113).As a preventive action the installation documention was improved.A finite element analysis (fea) carried out simulating wrong installation of unistrut & its fixation parts to evaluate the impact on system performance with the result that none of the fixing parts will fall down, the system will work as intended, no obstruction during intended use.No potential safety and/or performance issue will occur due to this issue.Risk estimation revealed no unacceptable risk.The issue is further monitored and trended.The event was originally reported to the authorities as not enough information was available to make a definite reportability decision.Since that time, additional information was received which revealed that the event does not meet the criteria for reporting.

• Brand Name: PROXIDIAGNOST N90
• Common Device Name: SYSTEM, X-RAY, STATIONARY
• 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: 16591773
• Report Number: 3003768251-2023-00012
• Device Sequence Number: 2907054
• Product Code: JAA
• UDI-Device Identifier: 00884838085619
• UDI-Public: 00884838085619
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 06/11/2024

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: Other
• Device Model Number: 706100
• Device Catalogue Number: 706100
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/04/2022
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/22/2023
• Supplement Report FDA Received Date: 06/11/2024
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-0280-2024
• Patient Sequence Number: 1
• Patient Sex: Unknown