MAUDE Adverse Event Report: MERGE HEALTHCARE FUSION WORKSTATION; PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM

Model Number FUSION WORKSTATION V. 3.0

Device Problems Computer Software Problem (1112); Incorrect Measurement (1383)

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

Event Date 08/18/2011

Event Type  malfunction  

Manufacturer Narrative

Upon retrospective review, this issue was determined to be reportable as an mdr.

Event Description

After a period of time running the fusion workstation (fw) 3.0.2 p3 and later, the hounsfield measurement tool will report incorrect values.If the exam is closed, and user exits fw and logs back in to reopen the exam, the measurement will then be reported correctly.There appears to be no consistency to the method to invoke the error.The facility reported the measurements to be clearly incorrect upon viewing the results, and it happens about 1 out of every 500 studies.Customer needs to be using fw with 3rd party softwares (epic and powerscribe) to observe this issue.The user needs to link the studies in epic.There have been no reports of adverse events or misdiagnoses of a patient, however this was deemed a potential safety issue.

Manufacturer Narrative

Submitting this supplemental report to add fda correction and removal reference numbers.

• Brand Name: FUSION WORKSTATION
• 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: 5339508
• MDR Text Key: 34924470
• Report Number: 2183926-2015-00027
• Device Sequence Number: 1
• Product Code: LLZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K983401
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Health Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 12/31/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FUSION WORKSTATION V. 3.0
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/03/2013
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/13/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: Z-0294-2017; RES 75425
• Patient Sequence Number: 1
• Patient Age: 74 YR