MAUDE Adverse Event Report: GENERAL ELECTRIC GENERAL ELECTRIC; INNOVA

Model Number INNOVA 2000

Device Problems Insufficient Cooling (1130); Overheating of Device (1437)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/25/2016

Event Type  malfunction  

Event Description

On (b)(6) 2016 at approx 05:59, the ge innova had a fluoroscopy system failure (x-ray tube overheated) during pt procedure resulting in the inability to fluoroscope or visualize procedural area following an acute myocardial infarction.

• Brand Name: GENERAL ELECTRIC
• Type of Device: INNOVA
• Manufacturer (Section D): GENERAL ELECTRIC; chicago IL
• MDR Report Key: 6251491
• MDR Text Key: 65024309
• Report Number: 6251491
• Device Sequence Number: 1
• Product Code: JAA
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 01/10/2017

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
• Device Operator: Health Professional
• Device Model Number: INNOVA 2000
• 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: 01/10/2017
• Distributor Facility Aware Date: 12/25/2016
• Device Age: 12 YR
• Event Location: Hospital
• Date Report to Manufacturer: 01/10/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/10/2017
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Patient Weight: 89