MAUDE Adverse Event Report: GE MEDICAL SYSTEMS, LLC PRECISION 500D R&F X-RAY SYSTEM; SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE-I

Model Number 2290800

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem No Patient Involvement (2645)

Event Date 03/29/2019

Event Type  malfunction  

Manufacturer Narrative

Ge healthcare's investigation has been completed and the root cause of the detached collimator was determined to be a third-party servicing error.This precision 500d system was moved from another hospital and installed by a third-party service provider at (b)(6) radiology imaging in (b)(6) 2019.The ge healthcare field engineer (fe) arrived at the site to investigate the event and observed that all three set screws securing the collimator had loosened and this is what caused the detachment of the collimator.During his investigation, the fe also did not recognize the collimator model that was installed on the system.The precision 500d installation manual references two validated collimator models that can be used on the precision 500d system (2266999 and 5234954) but the collimator on this system was 2261765, which is not a validated model.The customer was unable to provide any information regarding the third-party service provider, so no details are available regarding the installation of the collimator.To correct this issue, the fe replaced the collimator with the correct model collimator.No further actions are needed.

Event Description

This report summarizes 1 malfunction events.On (b)(6) 2019, the radiographic technologist (rt) at valley radiology imaging in the united states reported that during a tabletop foot exam using their precision 500d system with model number 2290800, as they were positioning the collimator, the collimator detached from the tube.When the collimator detached, the rt caught the collimator from falling to the table.There was no injury to the operator or patient.

• Brand Name: PRECISION 500D R&F X-RAY SYSTEM
• Type of Device: SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE-I
• 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: 8837361
• MDR Text Key: 153261475
• Report Number: 2126677-2019-00007
• Device Sequence Number: 1
• Product Code: JAA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K081091
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/29/2019

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?: No
• Device Operator: No Information
• Device Model Number: 2290800
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/01/2019
• Initial Date FDA Received: 07/29/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/1970
• 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