MAUDE Adverse Event Report: GE MEDICAL SYSTEMS, LLC PRECISION 600; SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE

Device Problems No Display/Image (1183); Data Back-Up Problem (2902)

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

Event Date 11/07/2019

Event Type  malfunction  

Event Description

Pt was undergoing fluoroscopy imaging when the tech was not able to take an image or save the last image.Handle on fluoro system replaced.Fda safety report id# (b)(4).

• Brand Name: PRECISION 600
• Type of Device: SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE
• Manufacturer (Section D): GE MEDICAL SYSTEMS, LLC
• MDR Report Key: 9348257
• MDR Text Key: 167320064
• Report Number: MW5091178
• Device Sequence Number: 1
• Product Code: JAA
• 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: 11/18/2019

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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/19/2019
• 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: 30 YR