MAUDE Adverse Event Report: SIEMENS AG/SIEMENS HEALTHCARE GMBH ARCADIS ORBIC; IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM, MOBILE

Device Problems Device Displays Incorrect Message (2591); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

During a case today the site was attempting to do an automatic c-arm navigated scan with a navigation system and they got an error message on the c-arm and were unable to complete the spin.Using an arcadis orbic siemens (2006).All connections info say it is working correctly.Dial in the patient orientation on the c-arm, connectivity is good.Then "asp-tfe-e-54" on the siemens device.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: ARCADIS ORBIC
• Type of Device: IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM, MOBILE
• Manufacturer (Section D): SIEMENS AG/SIEMENS HEALTHCARE GMBH
• MDR Report Key: 17529570
• MDR Text Key: 321430059
• Report Number: MW5136495
• Device Sequence Number: 1
• Product Code: OXO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/08/2022

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?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2023
• Patient Sequence Number: 1