MAUDE Adverse Event Report: GE MEDICAL SYSTEMS SCS INNOVA IGS 520 OMEGA; INTERVENTIONAL FLUOROSCOPIC X-RAY

Lot Number 646532BU2

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

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/13/2023

Event Type  Injury  

Manufacturer Narrative

Udi not required.Legal manufacturer: hcs buc - 283 rue de la miniere france buc yvelines, 78530.Block a1, a2 and a4: all patient information was not provided by the customer ans it is recommended to not ask those information per eu regulations.

Event Description

Ge helthcare field engineer (fe) was informed by a customer that during a vascular exam a patient received a x-rays dose higher than 7 grays.The fe inspected the vascular system and replaced the microgrid, but it is not confirmed yet that its condition contributed to this high dose.The patient exam went well, and the patient does not show any skin injury few days after the exam.A high dose could lead to a delayed (after up to 6 weeks) radiation injury of the skin.Ge healthcareâ s investigation into the reported occurrence is ongoing.

Manufacturer Narrative

Patient information not provided.

Event Description

Ge helthcare field engineer (fe) was informed by a customer that during a vascular exam a patient received a x-rays dose higher than 7 grays.The fe inspected the vascular system and replaced the microgrid, but investigation showed that microgrid condition has not contributed to this high dose.The patient exam went well, and the patient does not show any skin injury few days after the exam.Several weeks after, the patient didn't show any radiation injury of the skin.Ge healthcare investigation showed that there was no issue with the system and the image quality was per specification for this complex type of exam with the system settings chosen by the customer.The high dose was due to increased record frame rate and no dose optimization.Therefore a training was provided to the customer for a better use of the dose optimization features of the system.

• Brand Name: INNOVA IGS 520 OMEGA
• Type of Device: INTERVENTIONAL FLUOROSCOPIC X-RAY
• 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: 17350951
• MDR Text Key: 319415116
• Report Number: 9611343-2023-00004
• Device Sequence Number: 1
• Product Code: OWB
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K181403
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/28/2023

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 Lot Number: 646532BU2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/23/2023
• Initial Date FDA Received: 07/19/2023
• Supplement Dates Manufacturer Received: 09/07/2023
• Supplement Dates FDA Received: 09/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/16/2014
• 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
• Patient Weight: 100 KG