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

Model Number MERGE PACS V 7.1.1

Device Problem Patient Data Problem (3197)

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

Event Date 05/05/2017

Event Type  malfunction  

Manufacturer Narrative

Upon investigation, merge support found patients were merged due to customer configuration settings.Based on these settings, merge pacs will merge two patients if they have the same mrn and ipid.The customer is responsible for assigning a unique ipid or a unique patient id prefix; otherwise, identity collisions/patient merges may occur.Merge support was able to assist the customer and explain they can configure their system to merge patients with additional information (matching criteria mrn, ipid, dob, last/first name) if needed.Merge pacs was performing as expected and did not fail to meet specifications.At this time, the investigation is complete, there are no other reports of merged patients from this customer, and no further 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) 2017, a customer reported that two different patient's studies were merged together into a single patient's record by the system automatically.Merge healthcare technical support investigated the customer's allegation and determined that two different patients had been merged together due to the patient's having matching mrn and ipid identifiers.Each patient's demographic information is stored and visible on the images in the report and would be detectable to the user when reviewing demographic information.There was no indication from the customer regarding any direct impact to patient care at this time.However, this issue could potentially cause a delay in patient care due to the inability to find a patient's information or a misdiagnosis if the patient's demographic information is not read and a treatment is applied to the incorrect patient.(b)(4).

• 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: 6617104
• MDR Text Key: 76947449
• Report Number: 2183926-2017-00116
• 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
• Report Date: 05/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: MERGE PACS V 7.1.1
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/05/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/25/2017
• 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