MAUDE Adverse Event Report: GE MEDICAL SYSTEMS SCS INNOVA IGS 540; SYSTEM, X-RAY, ANGIOGRAPHIC

Model Number XCA450

Device Problem Radiation Overexposure (3017)

Patient Problem Radiation Overdose (1510)

Event Date 09/04/2014

Event Type  Injury  

Event Description

No injury has been reported.It was reported that a patient received a radiation dose of approximately 13 gy, while being scanned during a long examination with an innova igs 540 system.There was no system failure or malfunction reported.

Manufacturer Narrative

This high air-kerma dose, not possibly reduced to the lowest by using dose reduction features provided by the system, is likely to result in a serious injury since it may take some time before having any radiation burn.Ge healthcare's investigation is ongoing.A follow up report will be submitted once the investigation has been completed.

Manufacturer Narrative

Additional patient information not available.Ge healthcare's investigation has been completed.Ge healthcare was informed that an extremely long case was performed on (b)(6) 2014.The exam was described to be a long and complex embolization procedure.During investigation for this exam on december 2, 2014 it was found that there was a cumulative exam dose around 13 gy.Then, on december 30, 2014 customer reported to ge healthcare that the patient was seen by doctor one week post-embolization procedure and had redness and rash to the right lower back in a 4 by 4 inch area.The patient did not receive additional medication due to this injury.The system was found to be operating per specifications during the exam under, and there is no evidence of any system malfunction.The fluoroscopy maximum dose rates, the system automatic exposure control and the dose display on the system were operating as specified.Ge healthcare's field service engineer confirmed that the dose related calibrations on this system were performed on (b)(6) 2014 approximately one month before the exam under investigation with no evidence of any system malfunction.During review of the exam and system logs analysis, it was found that the selected settings used for dsa (digital subtracted acquisitions) were close to the highest dose levels available on the system and most of the exam dose would have been delivered over a small patient body region.However, as the precise patient position or type of procedure is not known, it is not possible to correlate the patient rash and redness at lower right back with the gantry positions or dose distribution.Thus, this was a long, complex exam performed with high dose acquisition settings that resulted in a high exam dose.The high dose observed for this case was most probably caused by a long and complex embolization procedure on a large patient.The acquisition settings could have been modified to reduce the overall exam dose; however, these were based on the physician's clinical judgment and part of the risk/benefit balance.Detailed instructions on reducing dose and improving the image quality are provided in the innova igs 540 tilt operator manual (5422625-2-399) on december 16, 2014, customer confirmed that hospital staff is well trained in radiation safety.No further action is required at that time.

• Brand Name: INNOVA IGS 540
• Type of Device: SYSTEM, X-RAY, ANGIOGRAPHIC
• Manufacturer (Section D): GE MEDICAL SYSTEMS SCS; buc ; FR
• Manufacturer (Section G): GE MEDICAL SYSTEMS SCS; buc, ; FR
• Manufacturer Contact: tammy lee ; 3000 n. grandview, w450; waukesha, WI 53188 ; 2625482169
• MDR Report Key: 4380465
• MDR Text Key: 16305185
• Report Number: 9611343-2014-00078
• Device Sequence Number: 1
• Product Code: IZI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K122457
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/02/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: XCA450
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/02/2014
• Initial Date FDA Received: 12/26/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/27/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other