MAUDE Adverse Event Report: GE MEDICAL SYSTEMS SCS INNOVA 3100; INTERVENTIONAL FLUOROSCOPIC X-RAY

Model Number XCA323

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

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

Event Date 09/28/2023

Event Type  Injury  

Event Description

Customer reported to ge healthcare that a patient has been over exposed to radiation, it may be caused by a long fluoro procedure.Ge healthcare investigation is in progress.

Manufacturer Narrative

Udi_not_required.Legal manufacturer: hcs buc - 283 rue de la miniere france buc yvelines, 78530.Patient data requested, only height and weight were provided by the customer.Ge healthcare investigation in progress.H3 other text : device evaluation anticipated, but not yet begun.

Manufacturer Narrative

Based on the investigation including also the system log review, it has been concluded that the high dose received by the patient during the exam that took place in (b)(6) 2023 was due to a long needed procedure and settings adjusted to patient condition.There is no malfunction, neither use error.No injury was reported.No further correction are required as the system was fully functional during the event.

• Brand Name: INNOVA 3100
• 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: 18063663
• MDR Text Key: 327239314
• Report Number: 9611343-2023-00009
• 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,Followup
• Report Date: 12/21/2023

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: XCA323
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/23/2023
• Initial Date FDA Received: 11/03/2023
• Supplement Dates Manufacturer Received: 12/06/2023
• Supplement Dates FDA Received: 12/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/24/2005
• 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 Weight: 110 KG