MAUDE Adverse Event Report: GE OEC MEDICAL SYSTEMS, INC. C-ARM IMAGING UNIT GE OEC; INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM

Model Number 9900

Device Problems Loss of Data (2903); Operating System Becomes Nonfunctional (2996)

Patient Problem Insufficient Information (4580)

Event Date 04/11/2022

Event Type  malfunction  

Event Description

During erc procedure oec medical systems c-arm unit unable to save images, then froze.Final occlusion cholangiogram was unable to be performed.Fda safety report id # (b)(4).

• Brand Name: C-ARM IMAGING UNIT GE OEC
• Type of Device: INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): GE OEC MEDICAL SYSTEMS, INC.
• MDR Report Key: 14117532
• MDR Text Key: 289451285
• Report Number: MW5108999
• Device Sequence Number: 1
• Product Code: OWB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9900
• Device Catalogue Number: 9900
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 38 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American