MAUDE Adverse Event Report: VARIAN/GE GE ADVANTAGE CT SCANNER; RPM GATING SYSTEM

Device Problems Communication or Transmission Problem (2896); Connection Problem (2900); Loss of Data (2903); Patient Data Problem (3197)

Patient Problem No Information (3190)

Event Date 03/11/2016

Event Type  malfunction  

Event Description

A 4d ct scanning, after entire scan was done, which is long and delivers more than the usual amount of dose, the data did not save for planning use.The file was corrupt.We had to re-acquire the scan in its entirety.We think the ge advantage simulator workstation to varian rpm connection is at least partially to blame.This same issue has occurred at least 3 times in our clinic.It appears to be the connection between the ge advantage ct simulator, the advantage workstation and the varian rpm gating system that corrupts the acquired data.

• Brand Name: GE ADVANTAGE CT SCANNER
• Type of Device: RPM GATING SYSTEM
• Manufacturer (Section D): VARIAN/GE
• MDR Report Key: 5700349
• MDR Text Key: 46668681
• Report Number: MW5062667
• Device Sequence Number: 1
• Product Code: IYE
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 19 YR