MAUDE Adverse Event Report: MERGE HEALTHCARE MERGE UNITY PACS; PICTURE AND ARCHIVING COMMUNICATIONS SYSTEM

Model Number UNITY PACS R11.0.4

Device Problem Loss of Data (2903)

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

Event Date 11/08/2016

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 (b)(4) 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.Information was received from a (b)(4) administrator on (b)(6) 2016 reporting a missing report.The unity pacs audit trail states that the report was saved (b)(6) 2016.Merge support investigated and confirmed that a report was saved on the station.However, there was no document in the report directory.A blank word document was placed in the directory and the physician re-read the exam.There was no reported adverse event to a patient.However, reports needing to be re-dictated has the potential to delay patient treatment and/or diagnosis.(b)(4).

Manufacturer Narrative

It was determined that the exam report was triggered to save by the reading physician.There was a "report save" event in the audit trail, however, no exam report uploaded to the image server.The report directory was blank.It was unable to be determined if this incident was related to software or to site network failure.The exam was available for review at all times, and 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
• 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: 6157137
• MDR Text Key: 61872456
• Report Number: 2183926-2016-00808
• 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: 11/08/2016

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: UNITY PACS R11.0.4
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/08/2016
• Initial Date FDA Received: 12/08/2016
• Supplement Dates Manufacturer Received: 09/27/2017
• Supplement Dates FDA Received: 02/23/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/28/2016
• 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