MAUDE Adverse Event Report: MERGE HEALTHCARE FUSION WORKSTATION (VERSION 3.3); PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM

Model Number FUSION WORKSTATION V. 3.3

Device Problems Computer Software Problem (1112); Patient Data Problem (3197); Missing Test Results (3267)

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

Event Date 04/10/2013

Event Type  malfunction  

Manufacturer Narrative

Upon retrospective review, this issue was determined to be reportable as an mdr.The issue was occurring at this institution because of the particular workflow they use to load studies.The normal workflow is to double-click on the worklist and all of the studies will load.The physician was trying to select particular studies to load.The code was fixed in (b)(4) version 3.3.4., and was applied to the system at the institution on (b)(4) 2014.

Event Description

The physician launched a case in a fusion workstation (fw) integrated with merge mammo and only priors came up, not the study requested.The physician clicked to view the (b)(6) 2013 study and the first case to load was the (b)(6) 2011 study.Therefore the current study did not launch in the viewer.There was no message to the user that the recent case was not loaded however all images maintained the date and time stamp.The reporter identified this as a potential safety issue in the event the physician misdiagnosed the patient, being unaware of the missing studies.

Manufacturer Narrative

The correction report (b)(4) that was referenced in the initial mdr was cancelled by fda.

• Brand Name: FUSION WORKSTATION (VERSION 3.3)
• 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: 5339344
• MDR Text Key: 34885638
• Report Number: 2183926-2015-00024
• 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: Biomedical Engineer
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 12/31/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FUSION WORKSTATION V. 3.3
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/10/2013
• Initial Date FDA Received: 12/31/2015
• Supplement Dates Manufacturer Received: 04/10/2013
• Supplement Dates FDA Received: 07/03/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/03/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: 2183926-01/04/2016-028-C
• Patient Sequence Number: 1
• Patient Age: 45 YR