MAUDE Adverse Event Report: GE MEDICAL SYSTEMS SCS INNOVA 3131-IQ; INTERVENTIONAL FLUOROSCOPIC X-RAY SY

Model Number XVA311

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Radiation Overdose (1510)

Event Date 12/21/2015

Event Type  Injury  

Manufacturer Narrative

Ge confirmed that medical staff tried taking a record view at steep angulations, creating an average patient thickness higher than normal mean ept (effective patient thickness) inhibiting the record exposure.This error occurred 17 times aborting dsa (digital subtracted angiography).Investigation revealed on (b)(6) 2016 that peak incident air kerma for this exam was 13.7 gy.System logs and service history confirmed no evidence of system malfunction and the system was calibrated per specifications.When the specified exposure techniques reach a limit, x-ray tube will not expose at high energy, which will eventually inhibit high power record or dsa exposures while still providing fluoroscopy.Dsa was inhibited due to large patient and continuous attempts of powerful acquisitions with insufficient time for the x-ray tube to cool down properly aborting dsa acquisitions.This is a system specification limit for high power acquisitions like dsa for thick patients.The high dose reported for this exam resulted from the long and complex interventional procedure on a large patient with several high dose dsa acquisitions at steep angulations.Detailed instructions on reducing dose and improving image quality are provided in the operator manual.For this case, exam parameters like the length of exam, high patient thickness, many dsa acquisitions, and high dose protocol were determined based on the physician¿s clinical judgment for obtaining the best image quality.It was confirmed that hospital staff is experienced and familiar with the innova system.The staff is aware of system specifications and exposure technique limits.Based on this analysis, no further action is required.

Event Description

It was reported that during a very difficult long exam procedure (spinal arteriovenous malformation) with a total of 18 arterial accesses on a large patient, the record exposure was inhibited.During investigation of this event, ge healthcare examined the system logs and discovered that a patient received a peak skin dose around 13 gy in the same body area.There is no report of radiation burn or adverse effect to the patient.No injury has been reported.

• Brand Name: INNOVA 3131-IQ
• Type of Device: INTERVENTIONAL FLUOROSCOPIC X-RAY SY
• 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: 5613355
• MDR Text Key: 43838245
• Report Number: 9611343-2016-00007
• Device Sequence Number: 1
• Product Code: OWB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K052412
• 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
• Report Date: 04/21/2016

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: XVA311
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/29/2016
• Initial Date FDA Received: 04/27/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/02/2011
• 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: 64 YR
• Patient Weight: 113