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

Model Number 709031

Device Problem Patient Data Problem (3197)

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 one image of a patient was displayed in an other patient's folder.There was no harm reported.

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.

• Brand Name: COMBIDIAGNOST R90
• Type of Device: 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: 12934779
• MDR Text Key: 281760129
• Report Number: 3003768251-2021-10017
• Device Sequence Number: 1
• Product Code: JAA
• UDI-Device Identifier: 00884838101456
• UDI-Public: 00884838101456
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2021
• 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
• Date Manufacturer Received: 10/15/2021
• Was Device Evaluated by Manufacturer?: Yes
• 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