MAUDE Adverse Event Report: GE MEDICAL SYSTEMS SCS INNOVA IGS 530; ANGIOGRAPHIC X-RAY SYSTEM

Model Number XCA320

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Radiation Overexposure (3017)

Patient Problems Chemical Exposure (2570); No Patient Involvement (2645)

Event Date 03/03/2016

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 7.57 gy in the same body area but did not report radiation burn or adverse effect to patient.No injury has been reported.

Manufacturer Narrative

The customer reported to a ge healthcare (gehc) technical engineer that an exam performed on (b)(6) 2016 exceeded the dose threshold limit of 5gy.No injury has been reported.Initial analysis indicated that the patient received a peak skin dose of 7.57 gy in the same body area during the exam procedure.Further gehc engineering investigation analysis was performed using information from the gehc field engineer and logs from the system which showed that the total exam duration for this exam was 2 h 3 min with a total dose of 7.571 gy, 6.046 gy from fluoroscopy acquisitions and 1.525 gy from digital subtraction angiography (dsa) acquisitions, and the peak incident dose was 4.6 gy.The most probable root cause for the high dose would be a long exam performed on a large patient with appropriate acquisition settings.Acquisition settings were selected by the user based on the physician's clinical judgment for obtaining the best image quality for diagnosis.The patient did not sustain any radiation induced injury.Because the localized skin peak dose was less than 7.5 gy, the likelihood of permanent radiation damage is remote.This system is not covered under a gehc service contract.All system calibrations were completed successfully and there was no indication of any system malfunction.Detailed instructions on reducing dose and improving image quality are provided in the innova igs systems cardiovascular imaging system operator manual.These instructions have been reviewed and found to be appropriate.No system malfunction has been identified.The system worked as intended and per specifications.No further action is required.

• Brand Name: INNOVA IGS 530
• Type of Device: ANGIOGRAPHIC X-RAY SYSTEM
• 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: 5555204
• MDR Text Key: 42098141
• Report Number: 9611343-2016-00005
• 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 faci
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 04/07/2016

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: XCA320
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/07/2016
• Initial Date FDA Received: 04/07/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/14/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/26/2013
• 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
• Patient Age: 65 YR
• Patient Weight: 116