MAUDE Adverse Event Report: GE HEALTHCARE C-PACS; RA 1000

Device Problems Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017); Insufficient Information (3190)

Patient Problem Misdiagnosis (2159)

Event Date 09/18/2018

Event Type  Injury  

Manufacturer Narrative

Udi not required.Weight could not be obtained.Ge healthcare's investigation is ongoing.A follow-up report will be submitted when the investigation is complete.Device evaluation anticipated, but not yet begun.

Event Description

The customer reported a delay in surgery (x 8 days) following a missed fracture.Patient required hospitalization (unknown time) post surgery.The patient presented in the er on (b)(6) 2018 with acute trauma.An xr ankle right complete was ordered by emergency room clinician.Three views were obtained on a long cassette, providing anatomy beyond ankle to include mid shaft calf.These views were submitted for interpretation on the ra 1000 after they were magnified by the technologist and manually saved.The radiologist received the exam in the most recent saved state (magnified) and provided report based on this presentation.The radiologist had the option to view images as acquired at all times.The findings identified no radiographic evidence of acute displaced "ossious" fracture or dislocation involving the right ankle.The patient sought repeated care on (b)(6) 2018, with a history of right lower leg pain.As a result, the clinician ordered a xr leg right lower tibia/fibula exam.Four views were obtained.These views were submitted for interpretation on the ra 1000, revealing "a transverse fracture through the tibial shaft." the initial images from (b)(6) 2018 were re-assessed on (b)(6) "2017" and addended as follows: "at the time of initial interpretation, the images were submitted in a magnified state that obscured visualization of the mid shaft tibial fracture.Upon reprocessing images, there is a nondisplaced midshaft tibial fracture apparent on these views." the patient required surgery on (b)(6) 2018 for rod placement to repair a right nondisplaced tibial shaft fracture.Post surgery findings: there has been open reduction and internal fixation of the tibial diaphysis fracture with no evidence of complication status post surgery.

Manufacturer Narrative

Corrected data: initial mdr included a typographical error in 'describe event or problem'.The date images were re-assessed was incorrectly identified as sept 25, 2017.The correct date images were re-assesed is sept 25, 2018.Event problem evaluation codes added.Investigation completed.Root cause was determined to be a use error.No product defect identified.The technologist inappropriately manipulated the image, as documented in asrt (american society of radiologic technologists) the practice standards for medical imaging and radiation therapy (effective 24 june 2018.User error: the radiologist did not expect the image to have been saved in a zoomed state, with anatomy removed from view.

• Brand Name: C-PACS
• Type of Device: RA 1000
• Manufacturer (Section D): GE HEALTHCARE; 500 west monroe; chicago IL 60661
• MDR Report Key: 8005893
• MDR Text Key: 125024075
• Report Number: 3004526608-2018-00001
• Device Sequence Number: 1
• Product Code: LLZ
• Combination Product (y/n): N
• PMA/PMN Number: K110875
• 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: 04/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 17 YR