MAUDE Adverse Event Report: GE MEDICAL SYSTEMS, LLC PRESTIGE SI; SYSTEM, X-RAY, FLUOROSCOPIC

Device Problems Detachment of Device or Device Component (2907); Device Fell (4014)

Patient Problem No Patient Involvement (2645)

Event Date 10/31/2018

Event Type  malfunction  

Manufacturer Narrative

A ge healthcare investigation has been initiated and is ongoing.A follow-up mdr will be provided when ge healthcare's investigation has been completed.Device evaluation anticipated, but not yet begun.

Event Description

On (b)(6) 2018, the radiographic technologist at (b)(6) center located in (b)(6) reported that when they entered the radiology exam room, they found the crt monitor on the monitor suspension was now on the ground.Nobody was in the exam room when the monitor fell and there were no injuries because of this event.

Manufacturer Narrative

Ge healthcare's investigation has completed, and the root cause was determined to be degradation of the monitor's support feet due to age.The ge field engineer arrived at the site and identified deterioration of the plastic monitor feet.Upon investigation, it was determined the feet have been installed for approximately 20 years and therefore aged beyond their intended design life.The site was corrected by installing an lcd monitor.Ge healthcare has also initiated a field action to address the potential deterioration of the support feet in the installed base.This field action was reported to the fda per 21 cfr part 806 under correction and removal number 2126677-04/10/19-006-c on 10-apr-2017.

• Brand Name: PRESTIGE SI
• Type of Device: SYSTEM, X-RAY, FLUOROSCOPIC
• Manufacturer (Section D): GE MEDICAL SYSTEMS, LLC; 3000 n grandview blvd.; waukesha, WI 53188
• MDR Report Key: 8117211
• MDR Text Key: 128879872
• Report Number: 2126677-2018-00019
• Device Sequence Number: 1
• Product Code: JAA
• Combination Product (y/n): N
• PMA/PMN Number: K943805
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 04/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: 2126677-04/10/19-006-C
• Patient Sequence Number: 1