MAUDE Adverse Event Report: GE MEDICAL SYSTEMS SCS INNOVA 4100; INTERVENTIONAL FLUOROSCOPIC X-RAY

Model Number XVA322

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

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

Event Type  Injury  

Manufacturer Narrative

Udi not required.Legal manufacturer: hcs buc - 283 rue de la miniere france buc yvelines, 78530.H3 other text : device evaluation anticipated, but not yet begun.

Event Description

Ge healthcare field engineer (fe) was informed by a customer that during a vascular exam a patient may have received a high x-rays dose.Gehc system logs analysis showed that the patient has received a x-rays dose higher than 7 grays.The patient exam went well, and the patient does not show any skin injury after the exam.A high dose could lead to a delayed radiation injury of the skin.Ge healthcare's investigation into the reported occurrence is ongoing.

• Brand Name: INNOVA 4100
• 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: 17421671
• MDR Text Key: 320015648
• Report Number: 9611343-2023-00006
• Device Sequence Number: 1
• Product Code: OWB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/30/2023

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 Model Number: XVA322
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/15/2023
• Initial Date FDA Received: 07/30/2023
• 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