MAUDE Adverse Event Report: ZIEHM IMAGING GMBH ZIEHM VISION RFD 3D C-ARM; SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE-INTENSIFIED

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

Event Type  malfunction  

Event Description

During surgery, surgeon complaint about ziehm c-arm and nav (navigation) accuracy.After performing a calibration verification with the calibration pegboard, it has been confirmed the average error value was above the limits.Ziehm navigation not accurate.Ziehm technician not available, so calibration had to be postponed.Reference report: mw5145287.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: ZIEHM VISION RFD 3D C-ARM
• Type of Device: SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE-INTENSIFIED
• Manufacturer (Section D): ZIEHM IMAGING GMBH
• MDR Report Key: 17699589
• MDR Text Key: 323092550
• Report Number: MW5145288
• Device Sequence Number: 1
• Product Code: JAA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/05/2023

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
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/06/2023
• Patient Sequence Number: 1