MAUDE Adverse Event Report: GE HANGWEI MEDICAL SYSTEMS CO., LTD. PROTEUS XR/A RADIOGRAPHIC SYSTEM; SYSTEM, X-RAY, STATIONARY

Model Number 2259973-3

Device Problem Detachment of Device or Device Component (2907)

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

Event Date 05/10/2019

Event Type  malfunction  

Manufacturer Narrative

A ge healthcare investigation has been initiated and is currently ongoing.A follow-up summary report will be submitted upon completion of the investigation.

Event Description

This report summarizes 1 malfunction events.On (b)(6) 2019, the radiographic technologist at (b)(6) hospital in the united states reported that as they were rotating the proteus system collimator with model number 2259973-3 for positioning during a patient exam, the collimator detached from the tube support.As the collimator detached, it detached in the technologists hands who then prevented the collimator from falling.The collimator did not impact a patient and there was no injury related to this event.

Manufacturer Narrative

Ge healthcareâ s investigation has been completed and the root cause of the collimator detachment could not be determined.A ge field engineer (fe) arrived at the site to investigate the event and determined the collimator detached from the mounting ring.The fe then identified the screw that connects the two collimator clamps that hold the collimator to the mounting ring was loose.The fe did not observe any damage to the collimator or its mounting hardware.A review of the systemâ s service history was performed, and it was determined the last time the collimator was serviced was approximately six months prior during an x-ray tube replacement.The fe who performed the x-ray tube change was interviewed and he confirmed that when he reinstalled the collimator, he followed the collimator installation instructions.In addition, the set screws torque was checked during the annual planned maintenance and was found to be adequate.To correct this issue, the fe replaced the collimator.No further actions are needed.

• Brand Name: PROTEUS XR/A RADIOGRAPHIC SYSTEM
• Type of Device: SYSTEM, X-RAY, STATIONARY
• Manufacturer (Section D): GE HANGWEI MEDICAL SYSTEMS CO., LTD.; west area of building no.3,; no.1 yongchang north road; beijing 10017 6; CH 100176
• MDR Report Key: 8837881
• MDR Text Key: 216604022
• Report Number: 9613445-2019-00006
• Device Sequence Number: 1
• Product Code: KPR
• Combination Product (y/n): N
• PMA/PMN Number: K993090
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 08/15/2019

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: 2259973-3
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/01/2019
• Initial Date FDA Received: 07/29/2019
• Supplement Dates Manufacturer Received: 08/12/2019
• Supplement Dates FDA Received: 08/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1