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

Model Number IGS 520 OMEGA CERBA

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

Patient Problems Radiation Burn (1755); Unintended Radiation Exposure (4565)

Event Date 07/01/2020

Event Type  Injury  

Manufacturer Narrative

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.Device evaluation anticipated, but not yet begun.

Event Description

On (b)(6) 2021, ge healthcare engineering team received the confirmation that during an exam performed on (b)(6) 2020, a patient received a high radiation dose of 27 gy during a multi-vessel coronary angiography in a large patient.The patient later presented a radiation burn, which was treated with a skin graft.

Manufacturer Narrative

Narrative block h6: ge healthcare investigation of this event was performed using information provided by ge healthcare field service engineer and logs from the system which showed that the total exam acquisition duration was of 75 minutes with a total dose of 27 gy.System calibrations were within specifications.No system malfunction has been identified.The most probable root cause for this high dose delivery is the exposure record time.Those settings are determined by the physician based on the radiographers clinical judgment and part of the risk/benefit balance.Detailed dose reduction instructions are clearly provided in the innova operator manual.These instructions have been reviewed and found to be appropriate.Proper training was given to the customer on dose protocol during system installation.No further action is required at this time.

• Brand Name: INNOVA IGS 520
• Type of Device: INNOVA 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: 12576611
• MDR Text Key: 274911134
• Report Number: 9611343-2021-00002
• Device Sequence Number: 1
• Product Code: OWB
• Combination Product (y/n): N
• Reporter Country Code: KU
• PMA/PMN Number: K181403
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date: 11/22/2021

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: IGS 520 OMEGA CERBA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/15/2021
• Initial Date FDA Received: 10/05/2021
• Supplement Dates Manufacturer Received: 09/15/2021
• Supplement Dates FDA Received: 11/22/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2018
• 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: 74 YR
• Patient Sex: Male
• Patient Weight: 105 KG