MAUDE Adverse Event Report: AGFA-GEVAERT HEALTHCARE GMBH NX WORKSTATION

Model Number NX 3.0.8950

Device Problems Computer Software Problem (1112); Improper or Incorrect Procedure or Method (2017); Device Displays Incorrect Message (2591)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/22/2016

Event Type  malfunction  

Event Description

We are submitting this medical device report today december 13, 2016.On november 22, 2016, the customer reported that while using an nx workstation with software version nx 3.0.8950 software and selecting the affected patient/exam from closed exams, initially the wrong image was linked to the exam and appeared.After a short time the wrong image was replaced by the correct image, however the wrong image was used for transmitting to pacs.To correct this issue, the user backed up all logs and rebooted the system.The correct image was then transferred to pacs.During the investigation by agfa november 24, 2016 - december 1, 2016, the root cause was identified as a memory leak which was introduced in the image processing software in nx 3.0.8950.The user received two warning messages of potential malfunctioning prior to the issue.The user did not follow the warning instructions and this resulted in the image of a patient being archived in another patient exam record.A restart of the system at that time would have prevented the malfunction from happening.As a preventive action, agfa has recommended the following to the customer: restart the system on a more regular basis.A daily restart would certainly be sufficient to prevent memory issues.The system is configured to display images by default in print mode although print automation is not active.Reconfiguring the system to display images in softcopy mode further reduces the impact of the memory leak on memory consumption.Agfa solution development is underway and a correction will be implemented for this issue.The memory leak is resolved in nx 3.0.9000.A supplemental report will be provided.There has been no reported patient harm for this event.

Event Description

On december 22, 2016 agfa has implemented a correction via agfa (b)(4) ((b)(4)) and an urgent safety notice was sent to affected consignees for this issue.On january 26, 2017, a mandatory service bulletin was released to provide documentation on how to deploy the correction for this issue.Any additional reporting for this correction activity will be reported to fda via 21 cfr 806 reporting via agfa id - (b)(4) ((b)(4)).There has been no reported patient harm for this event.

• Brand Name: NX WORKSTATION
• Type of Device: NX WORKSTATION
• Manufacturer (Section D): AGFA-GEVAERT HEALTHCARE GMBH; max planck strasse 1; peissenberg bayern, germany D8238 0; GM D82380
• Manufacturer (Section G): AGFA-GEVAERT HEALTHCARE GMBH; max planck strasse 1; peissenberg bayern, germany D8238 0; GM D82380
• Manufacturer Contact: cassandra mcgowan ; 10 south academy street; greenville, SC 29601 ; 8644211984
• MDR Report Key: 6171440
• MDR Text Key: 62691612
• Report Number: 9613152-2016-00002
• Device Sequence Number: 1
• Product Code: LLZ
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K053634
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Health Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 02/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NX 3.0.8950
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/22/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/13/2011
• 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