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

Model Number 5555000

Device Problems Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)

Patient Problem Death (1802)

Event Date 09/04/2019

Event Type  Death  

Manufacturer Narrative

Ge healthcare has initiated a root cause investigation which is ongoing.A follow-up report will be submitted when the investigation has completed.Patient identifier: patient identifier was not provided.Udi# (b)(4).Device evaluation anticipated, but not yet begun.

Event Description

On (b)(6) 2019, the customer at (b)(6) medical center reported that when they were performing a stat chest x-ray using their optima xr240amx mobile radiographic system on a nicu patient on (b)(6) 2019, the technologist completed the exam with the detector placed upside down under the patient.Upon completion of the exposure and during reprocessing of the image, the technologist attempted to correct the image orientation by rotating the image 180 degrees but first inadvertently flipped the image without realizing it.The technologist then proceeded to rotate the image 180 degree which resulted in an image orientation showing an ap supine chest, yet right and left orientation was reversed.Due to the need for sterility during the procedure, routine lead markers could not be used.The patient had a right sided pneumothorax, but the radiologist misdiagnosed as a left side pneumothorax and a chest tube was inserted in the incorrect lung.The patient expired.

Manufacturer Narrative

Ge "healthcareâ¿¿s" investigation has been completed and the root cause was determined to be due to use error.If the detector is placed incorrectly behind the patient, the system allows the user to rotate, flip and use the patient orientation functions to correct the orientation.For this case, the operator attempted to correct the image through rotation of the image 180 degrees but also unintentionally flipped (horizontal flip) the image.The operator also did not use external lead markers or choose to use the electronic markers during this patient exam.The image was then misdiagnosed as a right sided pneumothorax and a chest tube was inserted in the incorrect lung.There were no problems identified with the optima xr240amx system.Recommendations were made to the user to always to place the detector in the intended direction of the patient position to avoid any corrections post exposure and to use the electronic left/right marker functionality.No further actions are needed.

• Brand Name: OPTIMA XR240AMX
• Type of Device: SYSTEM, X-RAY, MOBILE
• Manufacturer (Section D): GE MEDICAL SYSTEMS, LLC; 3000 n grandview blvd.; waukesha, WI 53188
• Manufacturer Contact: steven walczak ; 3000 north grandview boulevard; waukesha, WI
• MDR Report Key: 9235992
• MDR Text Key: 163705637
• Report Number: 2126677-2019-00013
• Device Sequence Number: 1
• Product Code: IZL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K162990
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/20/2020

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/17/2019
• Initial Date FDA Received: 10/24/2019
• Supplement Dates Manufacturer Received: 01/16/2020
• Supplement Dates FDA Received: 01/20/2020
• 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
• Patient Outcome(s): Death