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

Model Number IGS 520 002

Device Problem Mechanical Problem (1384)

Patient Problem Insufficient Information (4580)

Event Date 01/08/2022

Event Type  malfunction  

Event Description

Over the past year, there was an instance wherein the system table won't move; brake release not responding, leading to an interruption in patient exam.Manufacturer was contacted.Needed new footswitch, resolved 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: 15698183
• MDR Text Key: 302680977
• Report Number: 15698183
• 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: 10/31/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IGS 520 002
• 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: 10/31/2022
• Type of Device Usage: Unknown
• Patient Sequence Number: 1