MAUDE Adverse Event Report: MERGE HEALTHCARE MERGE UNITY PACS; PICTURE AND ARCHIVING COMMUNICATIONS SYSTEM, PRODUCT CODE: LLZ,

Model Number UNITY PACS R11.1.1.1

Device Problem Loss of Data (2903)

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

Event Date 11/28/2016

Event Type  malfunction  

Manufacturer Narrative

Merge healthcare is further investigating the allegation from the customer to determine if any corrections or corrective actions are necessary.

Event Description

Merge unity pacs a medical image and information management system that is used for viewing, selection, processing, printing, telecommunications, and media interchange of medical images from a variety of diagnostic imaging systems a customer contacted merge healthcare on (b)(6) 2016 and reported seeing a message that a report did not cross to their radiology information system (ris) system (epic).After noticing the visit number did not match, the customer corrected it in merge unity and tried to resend.When the report opened, it was blank.The customer was unable to view the report.The merge healthcare unity support technologist placed a blank word document in the report directory on the image server.This allowed the exam to be re-read by the physician and the report saved and was accessible.(b)(4).

Manufacturer Narrative

Exam was available for review.The issue was identified by the pacs admin during internal qc work viewing failures of hl7 interfaces.Logs for this station/incident were unavailable for review.There was a "report save" event in the audit trail, however, no exam report uploaded to the image server.It was unable to be determined if this incident was related to software or to site network failure.The report was re-read by the physician.No further evaluation/investigation will be performed regarding this incident.

• Brand Name: MERGE UNITY PACS
• Type of Device: PICTURE AND ARCHIVING COMMUNICATIONS SYSTEM, PRODUCT CODE: LLZ,
• 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 drive; hartland, WI 53029 ; 2629123570
• MDR Report Key: 6207897
• MDR Text Key: 63368213
• Report Number: 2183926-2016-00823
• 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
• Type of Report: Initial,Followup
• Report Date: 11/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNITY PACS R11.1.1.1
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/27/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/29/2016
• 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