MAUDE Adverse Event Report: GE MEDICAL SYSTEMS SCS INNOVA IGS630; SYSTEM, X-RAY ANGIOGRAPHIC

Model Number XCA352

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)

Patient Problems Radiation Overdose (1510); No Known Impact Or Consequence To Patient (2692)

Event Date 01/27/2016

Event Type  Injury  

Manufacturer Narrative

Ge healthcare¿s investigation into the reported occurrence is still ongoing.A follow-up report will be issued when the investigation has been completed.

Event Description

The hospital reported that the patient received a peak skin dose around 13.6 gy in the same body area but did not report radiation burn or adverse effect to patient.No injury has been reported.

Manufacturer Narrative

Customer will not provide patient information.On (b)(6) 2016 the radiation safety officer (rso) from (b)(6), reported to ge healthcare (gehc) field engineer (fe) that cumulative dose for a patient during exam on (b)(6) 2016 was high.The operator stated the system did not display cumulative dose on monitor only dose area product (dap) resulting in cumulative dose exceeding 3 gy.This investigation used information from gehc fe and system logs.On (b)(6) 2016 gehc fe confirmed dose reading is clear and visible on in room monitors.Fe confirmed system is working within specifications with no monitor malfunction.System dose management and related displays (live monitor-air kerma rate, cumulative air kerma-reference monitor: x-ray time, cumulative air kerma, cumulative air kerma times area product) were functioning properly.System was calibrated in (b)(6) 2015 with fluoro dose rate < 10r/min.Gehc engineering found peak incident air kerma for this exam was 13.6 gy.This long exam used digital subtraction acquisition (dsa) on large patient.The settings were likely determined by physician¿s clinical judgment for best image quality.Dsa are powerful acquisitions that can result in high dose in a short time.Patient sustained no radiation injury, burn or adverse effect.There is no evidence of system malfunction and system was properly calibrated.Site rso confirmed operators were trained by gehc during system installation and declined retraining.Probable root cause is either the user was not aware of location to monitor dose or ignored it.Based on this analysis, no corrective or preventive action is needed.No further action required.

• Brand Name: INNOVA IGS630
• Type of Device: SYSTEM, X-RAY ANGIOGRAPHIC
• Manufacturer (Section D): GE MEDICAL SYSTEMS SCS; 283 rue de la miniere; buc 78530 ; FR 78530
• Manufacturer (Section G): GE MEDICAL SYSTEMS SCS; 283 rue de la miniere; buc 78530 ; FR 78530
• Manufacturer Contact: joseph seliga ; 3000 n grandview blvd.; waukesha, WI 53188
• MDR Report Key: 5508094
• MDR Text Key: 40597927
• Report Number: 9611343-2016-00004
• 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: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/17/2016

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: XCA352
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/18/2016
• Initial Date FDA Received: 03/17/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/05/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/19/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other