MAUDE Adverse Event Report: GE OEC MEDICAL SYSTEMS, INC. CYSTO TABLE WITH FLUORO; SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE-INTENSIFIED

Model Number CI-K5-160-TS

Device Problems Mechanical Problem (1384); Output Problem (3005)

Patient Problem Insufficient Information (4580)

Event Date 09/16/2021

Event Type  malfunction  

Event Description

During a cystoscopy and tur for bladder.The ge uroview x-ray malfunctioned.The foot pedal stuck and was beeping.It was frozen.The engineer checked the system, rebooted, relay replaced, and indicator light on wall in operating room not functioning, replacement light bulb ordered.Fda safety report id # (b)(4).

• Brand Name: CYSTO TABLE WITH FLUORO
• Type of Device: SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE-INTENSIFIED
• Manufacturer (Section D): GE OEC MEDICAL SYSTEMS, INC.
• MDR Report Key: 12568834
• MDR Text Key: 274769142
• Report Number: MW5104339
• Device Sequence Number: 1
• Product Code: JAA
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 09/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CI-K5-160-TS
• Was Device Available for Evaluation?: Yes
• 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: 54 YR
• Patient Weight: 95