MAUDE Adverse Event Report: GE MEDICAL SYSTEMS, LLC DISCOVERY XR650 DIGITAL RADIOGRAPHIC IMAGING SYSTEM; SYSTEM, X-RAY, STATIONARY

Model Number GTC14064PF-2

Device Problem Device Tipped Over (2589)

Patient Problem No Patient Involvement (2645)

Event Date 06/27/2019

Event Type  malfunction  

Manufacturer Narrative

Ge healthcare's investigation has completed and the root cause for the wall stand tipping could not be determined.The ge field service engineer (ge fse) arrived at the site to investigate the system and identified the incorrect wall stand floor anchors were installed in addition to the anchors were also cut.Because these anchors were cut at the threads, the screw engagement was decreased and when the ge fse loosened them to fix the leveling concern, there was not enough engagement to support the wall stand.An interview was conducted with the user who confirmed their in-house service representative never performed service regarding the floor anchors.The ge service history was evaluated, and it was determined ge also never performed service regarding these floor anchors.The ge fse who last performed the preventive maintenance (pm) was interviewed and it was confirmed the correct floor anchors were installed when the last pm was completed.Therefore, the root cause is unknown.No further actions are needed.Manufacturer type of report: voluntary malfunction summary report.

Event Description

This report summarizes 1 malfunction events.On 27-jun-2019, the ge field engineer (fe) was performing servicing on the discovery xr650 fixed radiographic system at (b)(6) regarding the x-ray tube centering to the wall stand.During troubleshooting of this centering issue, the fe identified the wall stand anchoring bolts were loose.After the fe removed one of the front anchor bolts to inspect it, the fe exited the immediate area to obtain a different tool and this is when the wall stand tipped over.There were no patients or operators in the room at the time of the incident and the wall stand did not impact the fe when it tipped over.There was no injury regarding this event.

• Brand Name: DISCOVERY XR650 DIGITAL RADIOGRAPHIC IMAGING SYSTEM
• Type of Device: SYSTEM, X-RAY, STATIONARY
• Manufacturer (Section D): GE MEDICAL SYSTEMS, LLC; 3000 north grandview boulevard; waukesha, WI 53188
• Manufacturer Contact: steven walczak ; 3000 north grandview boulevard; waukesha, WI
• MDR Report Key: 9244709
• MDR Text Key: 219200029
• Report Number: 2126677-2019-00014
• Device Sequence Number: 1
• Product Code: KPR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K051967
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GTC14064PF-2
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/27/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/26/2009
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1