MAUDE Adverse Event Report: GE HEALTHCARE OPTIMA CT580 RT; SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED

Device Problems Electrical /Electronic Property Problem (1198); Fire (1245)

Patient Problem No Information (3190)

Event Date 12/17/2014

Event Type  malfunction  

Event Description

The equipment was just installed; it had not been turned over to the hospital, and was in the process of being tested, when a faulty electronic panel caught fire.A repair tech was called and came to replace the faulty electronic panel.Ge is investigating and will submit a report.

• Brand Name: OPTIMA CT580 RT
• Type of Device: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• Manufacturer (Section D): GE HEALTHCARE; 9900 w. innovation drive; rp2138; wauwatosa, WI 53226
• MDR Report Key: 4506478
• MDR Text Key: 5491139
• Report Number: 4506478
• Device Sequence Number: 1
• Product Code: JAK
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 01/07/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/07/2015
• Event Location: Hospital
• Date Report to Manufacturer: 02/11/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1