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

Model Number	709031
Medical Device Problem Code	Patient Data Problem (3197)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that one image of a patient was displayed in an other patient's folder.There was no harm reported.
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.
Additional Manufacturer Narrative
Ref.Id: (b)(4).The combidiagnost r90 is a remote controlled multi-functional general r/f system.It is suitable for all routine radiography and fluoroscopy exams, including specialist areas like angiography or pediatric work, excluding mammography.Fluoroscopy exam images are reviewed via the rf viewer.First investigation by dxr application specialist confirmed that the issue could be reproduced, one dx image was displayed on the rf viewer for a different patient exam.It can happen if images are being exported whilst at the same time a fluoroscopy examination is in progress.Investigation by development dxr determined that the issue is caused by a defect in the application software.A capa investigation leads to a field safety corrective action fco70900057.The system has been removed from this hospital, therefore no correction are possible for this site.Risk estimation revealed no unacceptable risk.The issue is further monitored and trended.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 result and conclusion.

• 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 ; 222 jacobs st; cambridge, MA 02141 ; 6172455900
• MDR Report Key: 13099197
• Report Number: 3003768251-2021-10019
• Device Sequence Number: 19344633
• Product Code: JAA
• UDI-Device Identifier: 00884838101456
• UDI-Public: 00884838101456
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup

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: 12/01/2021
• Supplement Date Received by Manufacturer: 12/01/2021
• Initial Report FDA Received Date: 12/28/2021
• Supplement Report FDA Received Date: 02/03/2023
• 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