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

Model Number MERGE PACS 6.6.3.1

Device Problems Image Display Error/Artifact (1304); Loss of Data (2903)

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

Event Date 11/02/2016

Event Type  malfunction  

Manufacturer Narrative

At this time, merge healthcare is continuing their investigation and will determine if any further actions are required.It should be noted that there is other clinical information that can be utilized by customers to provide additional context regarding the treatment of a patient.

Event Description

Merge pacs is a picture archiving communication system that is intended to create and display two-dimensional and threedimensional 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 they used the qc editor tool to split a study and found the changes were not saved after saving and reopening the study.The qc editor tool did not give the customer a warning that changes were not saved.The qc editor tool is used to split, merge and/or delete series of images in a study.There is a potential for a delay in treatment that may lead to harm however the customer has not indicated that any harm to a patient occurred as a result of this issue.(b)(4).

Manufacturer Narrative

Merge healthcare pacs support completed a query that extracted all the records from the event log that indicate failures of the qc operation and corrected these studies.Development resolved this issue in version 6.6.3.2 and upgraded this clients servers to version 6.6.3.2.No further actions are required at this time.

• Brand Name: MERGE PACS
• Type of Device: PICTURE ARCHIVING COMMUNICATION SYSTEM PACS
• Manufacturer (Section D): MERGE HEALTHCARE; 900 walnut ridge dr; hartland WI 53029
• Manufacturer (Section G): MERGE HEALTHCARE; 900 walnut ridge dr.; hartland, wi 53029, WI 53029
• Manufacturer Contact: mike diedrick ; 900 walnut ridge dr.; hartland, WI 53029 ; 2629123570
• MDR Report Key: 6143545
• MDR Text Key: 61714528
• Report Number: 2183926-2016-00809
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 11/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MERGE PACS 6.6.3.1
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/02/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/07/2016
• 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