MAUDE Adverse Event Report: GE HEALTHCARE CENTRICITY PACS; PACS, PICTURE ARCHIVING AND COMMUNIC

Device Problems False Negative Result (1225); Human-Device Interface Problem (2949)

Patient Problem Abscess (1690)

Event Date 11/16/2017

Event Type  Injury  

Manufacturer Narrative

Patient information could not be obtained due to country privacy laws.The initial reporter is located outside the u.S., and therefore this information is not provided due to country privacy laws.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 the patient was discharged from inpatient hospital stay following radiologist review of historic abdominal ct exam from (b)(6) 2008 that cleared patient of any pathology.An abdominal ct exam was also performed on patient on (b)(6) 2017.The radiologist reviewed the (b)(6) 2008 exam as the current exam and provided report of findings of this image review on the (b)(6) 2017 report.The patient then came back into er (emergency room) 2 days later, on (b)(6) 2017 where she was diagnosed with a large abscess which required immediate surgical intervention and 2 days hospitalization.The customer reports that the patient is fully recovered.The customer reports that the exams displayed on monitors in a ge default ddp (default display protocol) which was not what user expected.

Manufacturer Narrative

Corrected data - report source identified as healthcare professional.Corrected data - date of device manufacture changed to dec.2, 2014.Additional manufacturer narrative - event problem evaluation codes added.Investigation completed.Root cause was determined to be a use error.No product defect identified.The site installed a new third party his (hospital information system) and with this system added many new exam procedures descriptions in which ge was not involved.These new exam procedures were not linked to the existing ddp's (default display protocols) being used by the site.When a study was viewed with any of these new exam procedures, since a local ddp was not defined, the ge default ddp was utilized to display the study and its comparisons.The ge default displays the current and prior studies on the opposite side of the monitor as the radiologist was expecting.The radiologist received a pop-up warning that the ge default ddp was being displayed, in addition there was a notice on the workstation toolbar that the default was in use, the correct study date was displayed on each open study and the comparison study had white border frames at the corners of each image sheet which designates that the image(s) is from a historical study and not part of the study currently being read.The site has added the new exam procedure descriptions to the relevant ddp's, however, they refused ddp advanced training offered by ge.

• Brand Name: CENTRICITY PACS
• Type of Device: PACS, PICTURE ARCHIVING AND COMMUNIC
• Manufacturer (Section D): GE HEALTHCARE; 540 w northwest hwy; barrington, IL
• Manufacturer Contact: john szalinski ; 500 w monroe; chicago, IL
• MDR Report Key: 7127570
• MDR Text Key: 95176702
• Report Number: 3004526608-2017-00001
• 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
• Type of Report: Initial,Followup
• Report Date: 04/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Other Device ID Number: UDI NOT REQUIRED
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/03/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/02/2014
• 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): Other