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

Model Number FUSION WORKSTATION 3.0

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

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

Event Date 03/23/2011

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Hounsfield measurements are used to measure tissue density and may be used as an input to clinical decision making.After a period of time running fusion workstation 3.0.2 p3 and later, the hounsfield measurement tool (and reportedly other measurement tools) will report incorrect values.If the exam is closed and the user exits fusion workstation and then logs back in and reopens the exam, the measurement will then be reported correctly.The customer reported that measuring in matrix is not always accurate on two different workstations.Client does not consider it a major issue but does result in the doctors having to reboot these workstations.Once this is done then they function properly.

Manufacturer Narrative

Submitting this supplemental report to add fda correction and removal reference numbers.Note that the fda terminated the recall on dec.14/16.

• Brand Name: FUSION WORKSTATION
• Type of Device: PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM
• Manufacturer (Section D): MERGE HEALTHCARE; 900 walnut ridge dr.; hartland WI 53029
• Manufacturer (Section G): MERGE HEALTHCARE; 900 walnut ridge dr.; hartland WI 53029
• Manufacturer Contact: michael diedrick ; 900 walnut ridge dr.; hartland, WI 53029 ; 2629123570
• MDR Report Key: 5339701
• MDR Text Key: 34885659
• Report Number: 2183926-2015-00112
• 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: 01/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FUSION WORKSTATION 3.0
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/23/2011
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/03/2013
• 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