MAUDE Adverse Event Report: GE MEDICAL SYSTEMS SCS INNOVA IGS 630

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unintended Radiation Exposure (4565)

Event Date 07/13/2021

Event Type  Injury  

Manufacturer Narrative

Patient information are not provided yet.No system malfunction has been identified till now.Ge healthcare's investigation is ongoing.A follow up report will be submitted when the investigation is completed.Full udi is (b)(4).Initial reporter email address not provided.Manufacturing date will be completed in the follow-up report.Ge healthcare's investigation is ongoing.A follow-up report will be submitted when the investigation is completed.

Event Description

On (b)(6) 2021, ge healthcare engineering team discovered that during an exam performed on (b)(6) 2021, a patient received a high radiation dose during an exam.Patient received a localized peak skin dose of 7,3 gy in the same body area.Neither radiation burn nor adverse effect to the patient has been reported by the customer.This event is reported as serious injury whereas there is no actual injury on the patient because it is likely to result in a serious injury with regards to the amount of radiation received by the patient, and no system malfunction has been identified till now.

• Brand Name: INNOVA IGS 630
• Type of Device: INNOVA IGS 630
• 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: mounir zaouali ; 283 rue de la miniere; buc 78530 ; FR 78530
• MDR Report Key: 12982287
• MDR Text Key: 282093305
• Report Number: 9611343-2021-00003
• Device Sequence Number: 1
• Product Code: OWB
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K181403
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/13/2021

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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/13/2021
• Initial Date FDA Received: 12/13/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Other