MAUDE Adverse Event Report: GENERAL ELECTRIC, CO GE 16 SLICE BRIGHTSPEED; SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED

Model Number 717724CT

Device Problems Signal Artifact/Noise (1036); Gas/Air Leak (2946)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/07/2019

Event Type  malfunction  

Event Description

Patient underwent unenhanced ct brain scan.Upon tilting the gantry, artifact was present.An air bubble was in the hermit tank causing the artifact.Hermit tank was replaced.

• Brand Name: GE 16 SLICE BRIGHTSPEED
• Type of Device: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• Manufacturer (Section D): GENERAL ELECTRIC, CO
• MDR Report Key: 8339534
• MDR Text Key: 136885153
• Report Number: MW5084067
• Device Sequence Number: 1
• Product Code: JAK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 717724CT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 58 YR