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

Model Number UNITY PACS R11.0.455.12641

Device Problems Loss of Data (2903); Data Problem (3196)

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

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.On 06/24/2016, merge was notified that on an unknown date, it was noted that reports were missing from exams after dictation.A review of the customer's audit trail indicated that the reports were saved.However, further investigation by merge support determined that the customer's network connection was terminated prior to the reports saving.Therefore, the reports were lost.In addition, the report was not salvageable and needed to be re-dictated.There was no reported adverse event to a patient.However, reports not associating to an exam and needing to be re-dictated has the potential to delay patient treatment and/or diagnosis, especially if the physician or health care professional is not aware that the report is not attached.(b)(4).

Manufacturer Narrative

Merge support conducted an investigation through reviewing audit trails and history logs.A review of the customer's audit trail indicated that the reports were saved.However, further investigation by merge support determined that the customer's network connection was terminated prior to the reports saving.Universal manager (um) logs show that crashes may occur before the [report approved] event however completed the [exam read] event.This resulted in the exam being marked read but with a missing report.The customer was advised to have the user re-dictate the report.An investigation was launched under (b)(4), however no plans have been made regarding the candidate fix version.If additional information is received from the associated investigation (b)(4), a supplemental report will be submitted.

• Brand Name: MERGE UNITY PACS
• Type of Device: PICTURE ARCHIVING AND 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: 5820248
• MDR Text Key: 50392976
• Report Number: 2183926-2016-00660
• 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: 06/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: UNITY PACS R11.0.455.12641
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/24/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/22/2016
• 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