MAUDE Adverse Event Report: MERGE HEALTHCARE MERGE PACS; PICTURE ARCHIVING COMMUNICATION SYSTEM (PACS), PRODUCT CODE: LLZ

Model Number MERGE PACS V6.6.2

Device Problem Device Issue (2379)

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

Event Date 04/15/2016

Event Type  malfunction  

Manufacturer Narrative

Merge support worked with customer on site to correct the patient data using the qc editor.Support and the contact at the site did a few records together and then the customer felt comfortable to correct any other accounts.

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 04/15/2016 ortho (b)(4) reported that existing information was getting overwritten since emr interface was activated.Ortho (b)(4) was to conduct a conversion of their mrn numbers before emr went live so that mrn numbers would match athena's mrn numbers.This conversion was not completed before emr was activated causing existing patient records to be updated incorrectly due to overwriting.Overwritten information could potentially lead to an incorrect treatment or diagnosis.Currently there is no indication of actual patient harm.(b)(4).

• Brand Name: MERGE PACS
• Type of Device: PICTURE ARCHIVING COMMUNICATION SYSTEM (PACS), PRODUCT CODE: LLZ
• Manufacturer (Section D): MERGE HEALTHCARE; 900 walnut ridge; 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: 5655743
• MDR Text Key: 45206741
• Report Number: 2183926-2016-00582
• 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: 04/15/2016

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: Health Professional
• Device Model Number: MERGE PACS V6.6.2
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/15/2016
• Initial Date FDA Received: 05/16/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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