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

Model Number 2259973-3

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

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/24/2021

Event Type  malfunction  

Event Description

On (b)(6) 2021, the customer at (b)(6) er in (b)(6) usa reported that as they were positioning the collimator during system setup using their proteus fixed radiographic system, the collimator detached from the tube.When the collimator detached, it was held up by the collimator cabling and therefore was prevented from falling.There was no injury related to this event.

Manufacturer Narrative

Ge healthcare investigation into the reported event has been initiated and is ongoing.A follow-up report will be submitted when the investigation has been completed.Device evaluation anticipated, but not yet begun.

Manufacturer Narrative

Ge healthcare's investigation has completed and the root cause for the detaching eclipse collimator could not be determined.The collimator is fixed on the tube by two clamps, and the two clamps are fastened together by a screw with lock washer.A torque of 5.6nm is applied to the screw to prevent the screw from loosening.The ge field service engineer (ge fse) arrived at the site to investigate the event and identified the screw used to fasten the two clamps was loose which caused the collimator to detach.The fse also confirmed there was no vibration source near the system, and there was no damage to collimator mounting hardware.The systems service history was evaluated, and it was identified the system received a preventative maintenance (pm) inspection approximately four months prior to the collimator detachment and this pm procedure consists of inspecting the collimator mounting hardware.The ge fse who performed the pm was interviewed and noted that the collimator mounting hardware was secure during this pm check.Therefore, the root cause could not be determined.To correct the issue, the ge fse reinstalled the original collimator and mounting hardware per the service instructions.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
• Manufacturer (Section G): GE HANGWEI MEDICAL SYSTEMS CO., LTD.; west area of building no.3; no.1 yongchang north road; beijing 10017 6; CH 100176
• Manufacturer Contact: steven walczak ; 3000 north grandview boulevard; waukesha, WI 53118-1696
• MDR Report Key: 12728698
• MDR Text Key: 281012668
• Report Number: 9613445-2021-00005
• Device Sequence Number: 1
• Product Code: KPR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K993090
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2259973-3
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/15/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1