MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS DMC GMBH COMBIDIAGNOST R90; TABLE, RADIOLOGIC

Model Number	COMBIDIAGNOST R90
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	08/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Reference id: (b)(4).The combidiagnost is a remote-controlled system, which supports general radiography and fluoroscopy imaging.As an option, a portable digital flat panel detector (model "sky plate") can be used for image capture.Philips received a complaint on combidiagnost r90 indicating that the remote alert of a mechanical heavy shock to the detector.The device was not in clinical use and there was no harm to patient or user.The remote service engineer (rse) confirmed, along with the customer, that the detector had been dropped.Since there was no service contract with philips for this site, no work was performed, and no resolution was provided to the customer.Based on the information available and the testing conducted, the cause of the reported problem was detector drop.The reported problem was confirmed by the customer.Thus, it is concluded that the detector was dropped by accident (use error).
Event or Problem Description
It was reported that the remote alert of a mechanical heavy shock to the detector.The device was not in clinical use and there was no harm to patient or user.

• Brand Name: COMBIDIAGNOST R90
• Common Device Name: TABLE, RADIOLOGIC
• 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: 22892437
• Report Number: 3003768251-2025-000111
• Device Sequence Number: 5916154
• Product Code: JAA
• UDI-Device Identifier: 00884838076747
• UDI-Public: (01)00884838076747
• Combination Product (Y/N): N
• Initial Reporter Country: RS
• PMA/510(K) Number: K163210
• 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): 08/26/2025

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: COMBIDIAGNOST R90
• Device Catalogue Number: 709030
• 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: 08/01/2025
• Initial Report FDA Received Date: 08/26/2025
• 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): Yes
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown