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

Model Number UNITY PACS 11.0.5

Device Problems Computer Software Problem (1112); Loss of Data (2903)

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

Event Date 08/15/2020

Event Type  malfunction  

Event Description

Merge unity pacs is 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 (b)(6) 2020, a customer contacted merge healthcare to inform us that an exam report was missing from a recent exam.Clicking on the report button results in an error stating "the report is not found".Attempting to open the report with transcription results in an error stating "object not found." upon investigation and troubleshooting by merge healthcare support, it was determined that he report was saved, but investigating the containing folder indicated that no data was uploaded at the time.There was a report save event in audit trail.Using the revision button from the dictation dialog box, the report template was re-generated and the report was then viewable as expected.This has the potential to delay patient treatment and/or diagnosis.There have been no reports of patient injury or harm as a result of this issue.Reference complaint (b)(4).

• Brand Name: MERGE UNITY PACS
• Type of Device: PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM, PRODUCT CODE: LLZ
• Manufacturer (Section D): MERGE HEALTHCARE; 900 walnut ridge drive; hartland, wi
• Manufacturer (Section G): MERGE HEALTHCARE; 900 walnut ridge drive; hartland, wi
• Manufacturer Contact: brian bell ; 75 binney street; cambridge, ma ; 3540189
• MDR Report Key: 10411776
• MDR Text Key: 203700709
• Report Number: 2183926-2020-00029
• Device Sequence Number: 1
• Product Code: LLZ
• UDI-Device Identifier: 00842000100461
• UDI-Public: 00842000100461
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNITY PACS 11.0.5
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/20/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/26/2017
• 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