MAUDE Adverse Event Report: ZIEHM IMAGING GMBH ZIEHM VISION RFD (X-RAY SYSTEM); SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE-INTENSIFIED

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

Ziehm tracker interface was delivered with wrong screw head t30h instead of t27h; the screwdriver bit delivered with the kit however was t27h."this report reflects information received by fda in the form of a notification per 803.22 (b)(2)".

• Brand Name: ZIEHM VISION RFD (X-RAY SYSTEM)
• Type of Device: SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE-INTENSIFIED
• Manufacturer (Section D): ZIEHM IMAGING GMBH
• MDR Report Key: 17661652
• MDR Text Key: 322487395
• Report Number: MW5145103
• 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: 08/29/2023

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: 08/30/2023
• Patient Sequence Number: 1