MAUDE Adverse Event Report: MERGE HEALTHCARE MERGE ORTHOPACS; PICTURE ARCHIVING COMMUNICATION SYSTEM (PACS)

Model Number MERGE ORTHOPACS

Device Problem Device Issue (2379)

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

Event Date 03/07/2016

Event Type  malfunction  

Manufacturer Narrative

Merge healthcare is further investigating the customer's allegation and will determine if any corrections or corrective actions are required.

Event Description

Merge pacs is a picture archiving communication system that is intended to create and display two-dimensional and three-dimensional images of anatomy from a series of digitally acquired images.Pacs is designed and marketed for soft copy reading, communication, and storage of studies produced by digital modalities.On (b)(6) 2016 a customer reported that while reviewing images with the use of the "oxford partial knee twin-peg" template, found that the template showed text that stated the incorrect view of the knee image.The text should have read right rather then left.This issue has a potential to lead to an inaccurate diagnosis or treatment of the wrong knee.The customer reported that the physician noticed the issue before misdiagnosing the incorrect knee.There was no indication from the customer that there were any patients who were harmed due to this complaint.Additionally, the physician would have referenced the lead laterality marker within the image to note which knee will be diagnosed.Reference complaint number (b)(4).

Manufacturer Narrative

After further investigation, it was found merge healthcare removed "mirror" attribute and "view" attribute (left and right) in version 34.This change would be reflected in version 35.As a corrective action, the customer has been updated to reflect the current version of templates at this time.No additional corrective actions are needed.

• Brand Name: MERGE ORTHOPACS
• Type of Device: PICTURE ARCHIVING COMMUNICATION SYSTEM (PACS)
• Manufacturer (Section D): MERGE HEALTHCARE; 900 walnut ridge; hartland WI 53029
• Manufacturer (Section G): MERGE HEALTHCARE; 900 walnut ridge dr; hartland WI 53029
• Manufacturer Contact: mike diedrek ; 900 walnut ridge dr; hartland, WI 53029 ; 2629123570
• MDR Report Key: 5553134
• MDR Text Key: 42031684
• Report Number: 2183926-2016-00531
• Device Sequence Number: 1
• Product Code: LLZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K022881
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MERGE ORTHOPACS
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/07/2016
• Initial Date FDA Received: 04/06/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/30/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1