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

Model Number	709030
Medical Device Problem Codes	Poor Quality Image (1408); Device Handling Problem (3265); Device Fell (4014)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Ref.Id: (b)(4).The combi diagnost r90 is a digital motorized remote controlled x-ray system used for radiographic and fluoroscopic imaging.Philips field service engineer (fse) went on site.A replacement of the affected detector is necessary.No details were provided about the circumstances when the detector fell down.As the customer did not make other claims, it is concluded that the detector was dropped by accident (use error).The affected detector was replaced.After replacement, the system meets manufacturers specification and is returned to use.Risk estimation revealed acceptable risk per risk benefit analysis, because actually, there is no feasible technical solution for this kind of ¿use error¿.This issue is further monitored and trended.
Event or Problem Description
The customer reported that the portable detector fell and has now artefacts in the image.A dropped detector can lead in worst case to a fracture in the foot.No injury reported.

• 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: 17480266
• Report Number: 3003768251-2023-00044
• Device Sequence Number: 2531475
• Product Code: JAA
• UDI-Device Identifier: 00884838076747
• UDI-Public: 00884838076747
• Combination Product (Y/N): N
• Initial Reporter Country: LU
• 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: Nurse
• Type of Report: Initial

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: 709030
• 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: 11/07/2022
• Initial Report FDA Received Date: 08/08/2023
• 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