MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS DMC GMBH COMBIDIAGNOST R90; SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE-INTENSIFIED

Model Number	COMBIDIAGNOST R90
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/09/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Ref id: (b)(4).Combidiagnost r90 is an x-ray unit for nearby controlled digital and conventional fluoroscopy and radiography.When the footrest is not locked into place on both sides, it can slide off the table when the table is tilted up.The field service engineer (fse) performed analysis and verified with the customer that the footplate had come off due to improper installation by the user.There are no photos that show how the installation was done incorrectly and no patient as injured.The footplate was reattached and relocked.After proper fitting, the footplate was checked and tested okay.System returned to clinical use with full functionality.
Event or Problem Description
It was reported that the device was in clinical use when the footstep of the table where the patient stands has come and seems to be broken.There was no patient or user impact.

• Brand Name: COMBIDIAGNOST R90
• Common Device Name: SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE-INTENSIFIED
• 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: 20607808
• Report Number: 3003768251-2024-00083
• Device Sequence Number: 20680841
• Product Code: JAA
• UDI-Device Identifier: 00884838101456
• UDI-Public: 00884838101456
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K203087
• 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): 11/05/2024

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: COMBIDIAGNOST R90
• Device Catalogue Number: 709031
• 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: 10/09/2024
• Initial Report FDA Received Date: 11/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/07/2024
• 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