MAUDE Adverse Event Report: GE MEDICAL SYSTEMS SCS DISCOVERY IGS740; DISCOVERY IGS 740

Device Problem Radiation Overexposure (3017)

Patient Problem Radiation Overdose (1510)

Event Date 10/13/2020

Event Type  Injury  

Manufacturer Narrative

All patient information was not provided by the customer.No system malfunction has been identified till now.Ge healthcare's investigation is ongoing.A follow up report will be submitted when the investigation is completed.Full udi is (b)(4).Ge healthcare's investigation is ongoing.A follow-up report will be submitted when the investigation is completed.

Event Description

A patient received a high radiation dose during an exam that was performed on (b)(6) 2020.Total exam dose was 11.9 gy during which patient received a localized peak skin dose of 11 gy in the same body area.Patient did not have an injury following this.

• Brand Name: DISCOVERY IGS740
• Type of Device: DISCOVERY IGS 740
• Manufacturer (Section D): GE MEDICAL SYSTEMS SCS; 283 rue de la miniere; buc 78530 ; FR 78530
• Manufacturer Contact: mounir zaouali ; 283 rue de la miniere; buc ; FR
• MDR Report Key: 11001543
• MDR Text Key: 221230996
• Report Number: 9611343-2020-00007
• 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: user facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/26/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/10/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1