MAUDE Adverse Event Report: GE MEDICAL SYSTEMS,LLC PRECISION; SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE-INTENSIFIED

Model Number	500D
Health Effect - Clinical Codes	Discomfort (2330); Unintended Radiation Exposure (4565)
Date of Event	03/31/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Outpatient arrived at the x-ray department to have an esophagram and video swallow performed.The patient was brought into the room in the xray department.The exam was begun with the esophagram using live fluoro.The radiologist then requested overhead imaging.The patient was exposed to radiation without producing an image twice as the equipment malfunctioned.Biomed was then called.The biomed engineer restarted the room, the room came back up still not working about 10 minutes later.The room then needed to be "hard wired" shut down by opening up the big box in the corner of the room.All this time our patient was laying on the table.The patient was elderly and very uncomfortable, although we provided as much comfort as possible during this time.Ultimately, the patient had to be moved to a different room to finish the exams that were ordered.Biomed follow up: ge system will not x-ray.A simple restart did not resolve the issue.The system was powered down, cabinet breaker disconnect and system left off for one minute.Reversed the process and powered on.After booting, the system was properly shut down and restarted.The system operated as intended.

• Brand Name: PRECISION
• Common Device Name: SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE-INTENSIFIED
• Manufacturer (Section D): GE MEDICAL SYSTEMS,LLC; 3000 n grandview blvd.; waukesha WI 53188
• MDR Report Key: 16712555
• Report Number: 16712555
• Device Sequence Number: 17957784
• Product Code: JAA
• UDI-Device Identifier: 00840682119238
• UDI-Public: 00840682119238
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/04/2023
• Report Date (Section F): 04/04/2023

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?: Yes
• Operator of Device: Other
• Device Model Number: 500D
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 04/11/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/11/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Male
• Date Report Sent to FDA: 04/04/2023