MAUDE Adverse Event Report: GE MEDICAL SYSTEMS SCS IGS5 30 AUTORIGHT OMEGA 5_3; SYSTEM, X-RAY, ANGIOGRAPHIC

Lot Number M3-22-106

Device Problems Imprecision (1307); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 07/11/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4).Legal manufacturer: hcs buc - 283 rue de la miniere france buc yvelines, 78530.Ge healthcare investigation is in progress.H3 other text : device evaluation anticipated, but not yet begun.

Event Description

On may 31, 2023 customer from brazil, reported to ge healthcare field service engineer that in some positions of the innova igs530 autoright omega 5_3 the dose is slightly above the maximum limit.No injury was reported.

Manufacturer Narrative

Based on the investigation including the review of the system logs, it has been concluded that the high dose received by the patient during the exam conducted the (b)(6) 2023, was due to a long cardiac procedure.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: IGS5 30 AUTORIGHT OMEGA 5_3
• Type of Device: SYSTEM, X-RAY, ANGIOGRAPHIC
• 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: 18063717
• MDR Text Key: 327239818
• Report Number: 9611343-2023-00010
• Device Sequence Number: 1
• Product Code: IZI
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K111209
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Physician
• 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 Lot Number: M3-22-106
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/24/2023
• Initial Date FDA Received: 11/03/2023
• Supplement Dates Manufacturer Received: 12/08/2023
• Supplement Dates FDA Received: 12/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/14/2023
• 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