MAUDE Adverse Event Report: MERGE HEALTHCARE MERGE PACS; SYSTEM, IMAGE PROCESSING, RADIOLOGICAL

Model Number 6.6.2.1

Device Problems Computer Software Problem (1112); Incorrect Software Programming Calculations (1495); Device Operates Differently Than Expected (2913)

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

Event Date 08/20/2015

Event Type  malfunction  

Event Description

Merge pacs (picture archiving communication system) is designed and marketed for soft copy reading, communication and storage of studies produced by digital modalities, including digital mammography.A customer reported (case (b)(4)) the cut lines are not showing correctly on a study in pacs.The cut lines would go from being vertical and then shift almost horizontal.The display is very obvious to the user and shows contradictory views which would cause the user to question what is happening.The images came from siemens (b)(4) scanner.An investigation found that siemens changed the resolution of the values of some dicom attributes causing an edge case which merge pacs did not handle appropriately.It was determined to be a potential safety issue for the patient in the event there was a misdiagnosis from viewing the incorrect measurements of a patient's images.

• Brand Name: MERGE PACS
• Type of Device: SYSTEM, IMAGE PROCESSING, RADIOLOGICAL
• 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 dr.; hartland, WI 53029 ; 2629123570
• MDR Report Key: 5437595
• MDR Text Key: 38226740
• Report Number: 2183926-2015-00151
• Device Sequence Number: 1
• Product Code: LLZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082144
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Health Professional
• 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 6.6.2.1
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/20/2015
• Initial Date FDA Received: 02/15/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/27/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: 2183926-02/15/2016-034-C
• Patient Sequence Number: 1