MAUDE Adverse Event Report: SIEMENS MEDICAL SOLUTIONS USA, INC. ARCADIS ORBIC 3D; C-ARM

Model Number 10143407

Device Problems Image Reversal (1358); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Information (3190)

Event Type  malfunction  

Event Description

During the procedure the surgeon ordered a 3-d fluoro spin with the siemens arcadis orbic, which was performed in the operating room.The images were reviewed by the surgeon and surgical intervention was altered based on the images provided by the device.It was later discovered that the positioning imputed prior to the scan being performed was selected supine rather than prone.This resulted in laterally images being reversed when reviewed by the surgeon.Concerned that the markers for right and left are small on the images produced.Questioned if the markers for right and left on the images could be enlarged to assist with verification of positioning.Questioned if an additional safety check with mandatory response could be added to confirm proper positioning has been selected prior to being able to start the scan.

• Brand Name: ARCADIS ORBIC 3D
• Type of Device: C-ARM
• Manufacturer (Section D): SIEMENS MEDICAL SOLUTIONS USA, INC.; 51 valley stream parkway; malvern PA 19355
• MDR Report Key: 3712659
• MDR Text Key: 4263254
• Report Number: 3712659
• Device Sequence Number: 1
• Product Code: JAA
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/18/2014

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: Other
• Device Model Number: 10143407
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/18/2014
• Device Age: 3 YR
• Event Location: Hospital
• Date Report to Manufacturer: 03/31/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/18/2014
• Patient Sequence Number: 1
• Patient Age: 70 YR