MAUDE Adverse Event Report: MERGE HEALTHCARE UNITY PACS (VERSION 11.0); PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM

Model Number UNITY PACS (V11.0)

Device Problems Computer Software Problem (1112); Incorrect Measurement (1383)

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

Event Date 07/21/2015

Event Type  malfunction  

Manufacturer Narrative

Upon retrospective review, this issue was determined to be reportable as an mdr.Unity 11.0.2 was released on 11/25/2015 to account for slices not equal to 3mm and to display a warning whenever slice thickness is not 3mm.

Event Description

Calcium scoring in merge unity pacs is a non-invasive way of obtaining information about the presence, location, and extent of calcified plaque on coronary arteries.During development of the next release of unity (version 11.0), the development team found that the current algorithm overestimates the calcium score for sites that obtain calcium scoring scans at slice thickness of <3mm and a slice interval of 0.It was presumed that the score for sites with a slice thickness of >3mm and a thickness of 0 would be underestimated, however performing coronary calcium scoring cts using a slice thickness of >3mm is unlikely.The error in the calculation minimally impacts evidence and mild evidence of coronary artery disease, and was deemed unlikely to cause adverse health consequences.There were no reported patients who were affected by the error.Unity 11.0.2 was released on 11/25/2015 to account for slices not equal to 3mm and to display a warning whenever slice thickness is not 3mm.

Manufacturer Narrative

Submitting this supplemental report to add fda correction and removal reference numbers.

• Brand Name: UNITY PACS (VERSION 11.0)
• Type of Device: PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM
• Manufacturer (Section D): MERGE HEALTHCARE; 900 walnut ridge drive; hartland WI 53029
• Manufacturer (Section G): MERGE HEALTHCARE; 900 walnut ridge drive; hartland WI 53029
• Manufacturer Contact: michael diedrick ; 900 walnut ridge drive; hartland, WI 53029 ; 2629123570
• MDR Report Key: 5339599
• MDR Text Key: 34886788
• Report Number: 2183926-2015-00029
• Device Sequence Number: 1
• Product Code: LLZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K041935
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 12/31/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNITY PACS (V11.0)
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/21/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/05/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: Z-2551-2016; RES 74846
• Patient Sequence Number: 1