MAUDE Adverse Event Report: GE MEDICAL SYSTEMS, LLC OPTIMA XR240AMX; SYSTEM, X-RAY, MOBILE

Model Number 5555000

Device Problems Image Display Error/Artifact (1304); Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)

Patient Problem Pneumothorax (2012)

Event Date 02/13/2019

Event Type  Injury  

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.Weight: although requested, the user was unable to provide the patient weight.Unique identifier: (b)(4).Device evaluation anticipated, but not yet begun.

Event Description

On (b)(6) 2019, the radiographic technologist at (b)(6) in the united states reported that when they were performing a chest x-ray using their optima xr240amx mobile radiographic system, the technologist mistakenly took the image with the detector upside down.After the image appeared on the system, it came up on the acquisition screen upside down and displayed the correct external lead marker.The technologist then corrected the image orientation by rotating the image 180 degrees but failed to change the dicom orientation tags after rotating the image.Therefore, when the image was sent to pacs, the image was hanging correctly and showed the correct external annotation marker, but the dicom orientation tag was incorrect.Therefore, the image read l (left) with an external marker and r (right) for the dicom tag.The emergency room (er) physician read the images using the dicom orientation tag and had a chest tube placed into the incorrect lung that resulted in a pneumothorax.

Manufacturer Narrative

Ge healthcareâs investigation has been completed and the root cause of the event was determined to be use error.After the image was taken and during image processing, the radiographic technologist (rt) needed to rotate the image but upon completion of image rotation, they did not rotate the dicom orientation tags to match the image.Furthermore, the emergency room physician then made the diagnosis ignoring the conflicting orientation markers.Because of the use error, the chest tube was placed within the incorrect lung causing a pneumothorax.The patient was intubated and transferred to another hospital.No further details regarding the patient status were provided.A ge application specialist was sent to the site to review with the director of radiology as well as the technologistâ¿¿s the process of correctly utilizing the patient orientation frame, so imaging would be displayed properly on pacs.A ge field engineer arrived on site to investigate the system but did not identify any issues with the system.The ge field engineer also disabled the patient dicom orientation feature per the userâs request.No further corrections or corrective and preventive actions are needed at this time.

• Brand Name: OPTIMA XR240AMX
• Type of Device: SYSTEM, X-RAY, MOBILE
• Manufacturer (Section D): GE MEDICAL SYSTEMS, LLC; 3000 north grandview boulevard; waukesha, WI 53188
• MDR Report Key: 8421720
• MDR Text Key: 138827875
• Report Number: 2126677-2019-00002
• Device Sequence Number: 1
• Product Code: IZL
• Combination Product (y/n): N
• PMA/PMN Number: K162990
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 04/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 5555000
• Device Lot Number: DF2401800289WK
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/13/2019
• Initial Date FDA Received: 03/14/2019
• Supplement Dates Manufacturer Received: 04/30/2019
• Supplement Dates FDA Received: 04/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 56 YR