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 they were unable to view an exam report from a recent exam.Upon investigation and troubleshooting by merge healthcare support, it was determined that the report never uploaded.Once a blank word doc was created, and the report template was regenerated, the customer was able to read the report successfully.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.(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: 10411790
• MDR Text Key: 203127814
• Report Number: 2183926-2020-00030
• 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: 07/21/2020
• 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