MAUDE Adverse Event Report: GE MEDICAL SYSTEMS, LLC; SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED

Device Problems Mechanical Problem (1384); Noise, Audible (3273)

Patient Problem Insufficient Information (4580)

Event Date 09/18/2020

Event Type  malfunction  

Event Description

Patient in ct scan as a stroke alert during the ct scan for head and neck.The unenhanced head performed.While setting up for the angiogram the ct machine had a scanner hardware malfunction and a grinding noise occurred during the smart-prep.The patient had to be moved to the other ct machine and the test was completed there.

• Type of Device: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• Manufacturer (Section D): GE MEDICAL SYSTEMS, LLC; 3000 n. grandview blvd; waukesha WI 53188
• MDR Report Key: 10599647
• MDR Text Key: 208972543
• Report Number: 10599647
• Device Sequence Number: 1
• Product Code: JAK
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 09/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/14/2020
• Date Report to Manufacturer: 09/29/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1