MAUDE Adverse Event Report: GE HEALTHCARE SYSTEMS CT750 HD CT SCANNER

Model Number DISCOVERY CT750HD

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem Cyst(s) (1800)

Event Date 05/11/2016

Event Type  Injury  

Event Description

Problems with high hounsfield units (hu#s) were identified shortly after the ge discovery hd750ct was placed into service on 10/30/2014.Initial medical physics testing on 10/30/2014 revealed a high hu bias on the hu # of water (subsequent annual medical physics testing in 2015 and 2016 verify the consistently high hu# of water in adult abdomens).In february 2015, ge healthcare was first notified of instances where renal cysts had elevated hu#s (compared to the same exams on the same pt on different ct scanners).A ct scan of the chest/abdomen/pelvis was performed on (b)(6) 2016 on the ge discovery hd750ct at the (b)(6).Lesions along the posterior aspect of the right lobe of liver measured 30 hy (hounsfield units).These were interpreted as metastatic disease.The pt had another ct chest/abdomen/pelvis done on (b)(6) 2016 on our philips ct scanner.The same lesions measured 14 hu.These are in consistent with cysts, not metastatic disease.This was later confirmed to be true with a follow up mri.In this event, the falsely elevated attenuation measurement on the ge ct scanner caused significant misinterpretation.Multiple requests have been made to ge healthcare (i.E., service requests and direct request to ge health senior director and senior engineering for physics and image quality); however, high water hu# artifacts persist.Therefore, (b)(6) staff radiologists do not have clinical confidence in the ge discovery ct750 hd scanner for diagnostic abdomen/pelvis studies.The majority of ct scans are abdomen/pelvis diagnostic studies; therefore, utilization of the ge discovery ct750 hd is severely limited.

• Brand Name: CT750 HD CT SCANNER
• Type of Device: CT SCANNER
• Manufacturer (Section D): GE HEALTHCARE SYSTEMS; waukesha WI 53188
• MDR Report Key: 6080963
• MDR Text Key: 59420152
• Report Number: MW5065828
• Device Sequence Number: 1
• Product Code: JAK
• 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: 11/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DISCOVERY CT750HD
• 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 Outcome(s): Hospitalization; Other