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

Model Number 610402ER1

Device Problem Operating System Becomes Nonfunctional (2996)

Patient Problem Insufficient Information (4580)

Event Date 05/05/2022

Event Type  malfunction  

Event Description

Patient was brought to er (emergency room) x-ray room for shunt series x-rays.After initial anteroposterior skull was obtained in the table bucky, the plate was turned crosswise for the lateral skull.The equipment then froze and could not take any exposures or click anywhere on the screen.After a couple of minutes of not being able to do anything further, turned the bucky back to lengthwise.Were eventually able to complete the exam, but needed to take 3 additional images to include all anatomy needed.

• Type of Device: SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE-INTENSIFIED
• Manufacturer (Section D): GE MEDICAL SYSTEMS; 3000 n. grandview blvd; waukesha WI 53188
• MDR Report Key: 14955524
• MDR Text Key: 295479856
• Report Number: 14955524
• Device Sequence Number: 1
• Product Code: JAA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/24/2022

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 610402ER1
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/24/2022
• Event Location: Hospital
• Date Report to Manufacturer: 07/08/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/08/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 15695 DA
• Patient Sex: Male