MAUDE Adverse Event Report: GE MEDICAL SYSTEMS, LLC REVOLUTION FRONTIER; SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED

Model Number REVOLUTION FRONTIER

Device Problem Output Problem (3005)

Patient Problem Insufficient Information (4580)

Event Date 08/07/2022

Event Type  malfunction  

Event Description

On at least three occasions in the past eight months, patients have been scanned outside of the intended start and end scan range due to the design of the scanner.In particular, our overall concern is that: on all 6 of our ge scanner models, the operator has the ability to "over scan".This can occur by incorrectly using the "shift" key button or even by typing in an incorrect s or i number.This unlimited adjustment of your start and end scan range has the potential for the operator to over scan the anatomy outside of the intended start and end scan range.Due to the capability of the "shift" key on the keyboard, we have had numerous techs make the same error while scanning over the past few years and they continue to do so.We feel it is important for ge to know that there is a clinical risk and to look into a resolution or develop a limitation of how high or low the operator can set up a scan range outside of the scout range.Manufacturer response for ct scanner, revolution frontier (per site reporter) we were told by the manufacturer that this is an "inherent operational limitation of the scanners.".

• Brand Name: REVOLUTION FRONTIER
• Type of Device: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• Manufacturer (Section D): GE MEDICAL SYSTEMS, LLC; 3000 n. grandview blvd; waukesha WI 53188
• MDR Report Key: 15401390
• MDR Text Key: 299680309
• Report Number: 15401390
• Device Sequence Number: 1
• Product Code: JAK
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 09/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: REVOLUTION FRONTIER
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/02/2022
• Device Age: 3 YR
• Event Location: Hospital
• Date Report to Manufacturer: 09/12/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 22630 DA
• Patient Sex: Female