MAUDE Adverse Event Report: GE MEDICAL SYSTEMS SCS DISCOVERY IGS740

Model Number XCA465

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

Patient Problems Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/20/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).Legal manufacturer: (b)(4).Based on the current information received, there was no device problem identified.High dose was given to the patient as a result of user/health professional decision.(b)(4).

Event Description

Gehc field engineer was informed on 20.Sept 2022 that a patient received high dose during an exam.Patient weight was 205 kg, the exam lasted the dosage was the decision of the doctor.No device malfunction was identified.

Event Description

On (b)(6) 2022, gehc was informed that an obese patient has received high radiation dose during a long procedure.Based on gehc investigation, no device problem was identified.High dose was given to the patient as a result of user/health professional`s decision.An obese patient received long, 4h20 mins treatment what resulted a high radiation dose (15,67 gy).Visual and radio alarm warned the healthcare professional, dose map was displayed as well.It was the radiographerâs clinical judgment to continue the procedure and part of the risk/benefit balance.After the exam, the patient was evaluated for any radiation induced injuries/ issues immediately following the procedure then again at 1 week after and 2 weeks after.There has been no injury noted to this point.The device worked according to its design and operator manual, no device issue has been found.The customer had already gone through dose refresher training and hence doctors and staff are aware of dose settings.No adverse trend has been identified.It was an isolated issue, no additional corrective or preventive actions are required.

• Brand Name: DISCOVERY IGS740
• Type of Device: DISCOVERY IGS740
• 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: zaouali mounir ; 283. rue de la miniere; buc 78530 ; FR 78530
• MDR Report Key: 15594748
• MDR Text Key: 301640736
• Report Number: 9611343-2022-00004
• 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: 11/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Model Number: XCA465
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/20/2022
• Initial Date FDA Received: 10/13/2022
• Supplement Dates Manufacturer Received: 09/20/2022
• Supplement Dates FDA Received: 11/15/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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: 205 KG