MAUDE Adverse Event Report: MERGE HEALTHCARE MERGE UNITY PACS

Model Number 11.0

Device Problems Computer Software Problem (1112); Patient Data Problem (3197)

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

Event Date 07/07/2015

Event Type  malfunction  

Manufacturer Narrative

Upon retrospective review, this issue was determined to be an mdr.

Event Description

Merge unity pacs is a medical image and information management system that allows viewing, selection, processing, printing, telecommunications, and media interchange of medical images from a variety of diagnostic imaging systems.(b)(6) hospital reported that if 2 images are captured for the same view and each view is associated to a tomo image, both tomos are associated to the first of those two images.The user may miss seeing the additional view which would help with diagnosis.What is expected is the ability to view tomo on first rcc image and ability to view tomo on the second rcc image.What is happening is that both tomos are associated to the first rcc image.The second rcc image has no tomo option available.Release 11.0 of unity has a defect which missed the associate of the second tomo.Design and testing failed to detect there could be more than 2 tomo images for same view.(b)(4).

• Brand Name: MERGE UNITY PACS
• Type of Device: PACS
• 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 rd; hartland, WI 53029 ; 2629123570
• MDR Report Key: 5437775
• MDR Text Key: 38227803
• Report Number: 2183926-2015-00429
• 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: user facility
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 02/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 11.0
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/07/2015
• 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: 2183926-02/15/2016-037-C
• Patient Sequence Number: 1