MAUDE Adverse Event Report: MERGE HEALTHCARE CEDARA I-READMAMMO; MAMMOGRAPHY VIEWER

Model Number CEDARA I-READMAMMO 8.0

Device Problem Device Operational Issue (2914)

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

Event Date 04/22/2016

Event Type  malfunction  

Manufacturer Narrative

Merge healthcare's designated complaint handling unit (dchu) contacted ge healthcare two times to obtain more information.Accordingly the response received on 5/19/2016 ".Sites have been upgraded from (b)(4) version 3.7.3.7 to (b)(4) version 3.7.3.9sp3.This has enabled the customers to bypass the error, because the license architecture using i(b)(4) version 3.7.3.9sp3 has a new design that uses workstation-based licenses.The old system used server-based licenses.(b)(4)'s server upgrade was started friday evening april 22, and by monday morning april 25, 2016, all of their mammo stations were able to view mammo images once again." the product is functioning as expected as of 4/25/2016 am according to ge healthcare.

Event Description

(b)(4) is medical image review workstation software.The product consists of features that allow qualified medical professionals to view patient medical images with the desired viewing protocol and workflow in order to optimize the efficient use of their time.On (b)(6) 2016 merge healthcare's customer, ge healthcare, reported that one of their install sites (b)(4) contacted ge heathcare to notify them that no license is available when launching (b)(4).As a result of this malfunction, users at (b)(4) were not able to read mammography images until the morning of (b)(6) 2016.This malfunction can result in delay in diagnosis or treatment.Merge healthcare's designated complaint handling unit (dchu) contacted ge healthcare to additional information on 5/3/2016.Accordingly the response on 5/19/2016 ".Sites have been upgraded from (b)(4) version 3.7.3.7 to (b)(4) version 3.7.3.9sp3.This has enabled the customers to bypass the error, because the license architecture using (b)(4) version 3.7.3.9sp3 has a new design that uses workstation-based licenses.The old system used server-based licenses.(b)(4)'s server upgrade was started friday evening april 22, and by monday morning april 25, 2016, all of their mammo stations were able to view mammo images once again." the product is functioning as expected as of 4/25/2016 am according to ge healthcare.(b)(4).

• Brand Name: CEDARA I-READMAMMO
• Type of Device: MAMMOGRAPHY VIEWER
• 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: 5684218
• MDR Text Key: 46064238
• Report Number: 2183926-2016-00590
• Device Sequence Number: 1
• Product Code: LLZ
• Combination Product (y/n): N
• PMA/PMN Number: K040648
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Remedial Action: Modification/Adjustment
• Type of Report: Initial
• Report Date: 04/22/2016

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: Other
• Device Model Number: CEDARA I-READMAMMO 8.0
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/19/2016
• Initial Date FDA Received: 05/26/2016
• Was Device Evaluated by Manufacturer?: No
• 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