MAUDE Adverse Event Report: GE MEDICAL SYSTEMS SCS INNOVA 3100-IQ; INTERVENTIONAL FLUOROSCOPIC X-RAY

Device Problem Radiation Overexposure (3017)

Patient Problem Radiation Overdose (1510)

Event Date 11/13/2014

Event Type  Injury  

Event Description

No injury has been reported.It was reported that a patient received a radiation dose above 12 gy, while being scanned with an innova 310-iq system during an emergency case.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

Patient information could not be obtained due to country privacy laws.Ge healthcare's investigation has been completed.Ge healthcare was informed that during a long pci (percutaneous coronary intervention) procedure on a large patient performed the same day.The cumulative exam dose around 13 gy.The exam was successfully completed and the patient undergoing this procedure did not sustain any radiation induced injury.The system was found to be operating per specifications during the exam.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.The high dose observed for this case was most probably caused by a long intervention on a large patient.There is a potential that the selected dose parameters were inappropriate and could have contributed to the high dose delivery.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 3100-iq system operator manual (5391979-4-399).On january 13, 2015, the ge healthcare technical operation manager confirmed that the customer is well-trained and aware about radiation safety.No further action is required at this time.

• Brand Name: INNOVA 3100-IQ
• Type of Device: INTERVENTIONAL FLUOROSCOPIC X-RAY
• 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 blvd, w450; waukesha, WI 53188 ; 2625482169
• MDR Report Key: 4339877
• MDR Text Key: 5175591
• Report Number: 9611343-2014-00076
• Device Sequence Number: 1
• Product Code: JAA
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K031637
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/13/2014

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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/13/2014
• Initial Date FDA Received: 12/12/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/27/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2004
• 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