MAUDE Adverse Event Report: GE MEDICAL SYSTEMS SCS ALLIA IGS 520

Model Number XCA510

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

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

Event Date 06/05/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4).Legal manufacturer: hcs buc - 283 rue de la miniere france buc yvelines, 78530.

Event Description

Ge helthcare 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 few days 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.

Manufacturer Narrative

During an exam performed on (b)(6) 2023 a patient received a high dose of 7.414.Gy.The ge healthcare field engineer , confirms that the system worked correctly.The patient does not show any skin injury few days after the exam.Ge healthcare investigation showed there was no malfunctions, and no use error on the system and high dose received by the patient (7,4gy) is due to a long needed fluoro exam on a thick patient.No further action was needed.

Event Description

During an exam performed on (b)(6) 2023 a patient received a high dose of 7.414.Gy.The ge healthcare field engineer , confirms that the system worked correctly.The patient does not show any skin injury few days after the exam.Ge healthcare investigation showed there was no malfunctions, and no use error on the system and high dose received by the patient (7,4gy) is due to a long needed fluoro exam on a thick patient.No further action was needed.

• Brand Name: ALLIA IGS 520
• Type of Device: ALLIA IGS 520
• 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: 17395555
• MDR Text Key: 319783418
• Report Number: 9611343-2023-00005
• Device Sequence Number: 1
• Product Code: OWB
• Combination Product (y/n): N
• Reporter Country Code: US
• 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 Model Number: XCA510
• Device Lot Number: M2-22-073
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/15/2023
• Initial Date FDA Received: 07/26/2023
• Supplement Dates Manufacturer Received: 09/11/2023
• Supplement Dates FDA Received: 09/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/04/2023
• 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
• Patient Age: 68 YR
• Patient Sex: Male
• Patient Weight: 102 KG