MAUDE Adverse Event Report: GE MEDICAL SYSTEMS INNOVA; INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM

Model Number IGS 520

Device Problem Mechanical Problem (1384)

Patient Problem Insufficient Information (4580)

Event Date 09/30/2021

Event Type  malfunction  

Event Description

Over the past year, there was an instance of the intensifier running very slow leading to an interruption of patient exam.Manufacturer was contacted.Replaced table rotator encoder resolving the problem for now.Manufacturer response for x-ray, (brand not provided) (per site reporter) manufacturer was contacted.Replaced table rotator encoder resolving the problem for now.

• Brand Name: INNOVA
• Type of Device: INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): GE MEDICAL SYSTEMS; 3000 n. grandview blvd.; waukesha WI 53188
• MDR Report Key: 15713817
• MDR Text Key: 302842774
• Report Number: 15713817
• Device Sequence Number: 1
• Product Code: OWB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IGS 520
• 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: 10/24/2022
• Event Location: Hospital
• Date Report to Manufacturer: 11/02/2022
• Type of Device Usage: Unknown
• Patient Sequence Number: 1