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

Model Number 709031

Device Problem Display or Visual Feedback Problem (1184)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

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 Description

The customer reported that the current image is mixed with the previous image.

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
• Type of Device: 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
• MDR Text Key: 273788574
• Report Number: 3003768251-2021-10012
• Device Sequence Number: 1
• Product Code: JAA
• UDI-Device Identifier: 00884838101456
• UDI-Public: 00884838101456
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K163210
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: 709031
• Device Catalogue Number: 709031
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/06/2021
• Initial Date FDA Received: 09/29/2021
• Supplement Dates Manufacturer Received: 09/06/2021
• Supplement Dates FDA Received: 11/08/2021
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1