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

Model Number	709031
Medical Device Problem Code	Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Ref.Id: (b)(4).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
The customer reported that the current image is mixed with the previous image.
Additional Manufacturer Narrative
Ref.Id:(b)(4).The combidiagnost system supports general radiography and fluoroscopy imaging.Digital images can be archived in external digital archives (pacs).The pacs system administrator is responsible for the proper import and display of such digital images from the connected acquisition systems.The issue was caused in the pacs so outside the philips acquisition system.No further information was provided as to the type of examination or how the images were mixed up.The hospital pacs system administrator solved the issue in the pacs.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.Correction: h6 results and conclusion code.

• 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 ; 222 jacobs st; cambridge, MA 02141 ; 6172455900
• MDR Report Key: 12547062
• Report Number: 3003768251-2021-10012
• Device Sequence Number: 3488477
• Product Code: JAA
• UDI-Device Identifier: 00884838101456
• UDI-Public: 00884838101456
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/05/2021

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: 709031
• Device Catalogue Number: 709031
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/06/2021
• Supplement Date Received by Manufacturer: 09/06/2021
• Initial Report FDA Received Date: 09/29/2021
• Supplement Report FDA Received Date: 11/08/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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