MAUDE Adverse Event Report: MERGE HEALTHCARE MERGE CADSTREAM; IMAGING PROCESSING SYSTEM

Model Number MERGE CADSTREAM V6.1.0.1010

Device Problem Device Issue (2379)

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

Event Date 12/01/2017

Event Type  malfunction  

Manufacturer Narrative

The issue, study reflects incorrect patient positioning on all images, was caused by incorrect data entry at the scanner.The user manual and reference guide describe the limitations of cadstream which caution diagnostic or other patient management decisions should not be based solely on the results of cadstream.

Event Description

Merge cadstream is intended to be used in the visualization, analysis, and reporting of magnetic resonance imaging (mri) studies.Merge cadstream supports evaluation of dynamic mr data acquired during contrast administration.Merge cadstream performs other user selected processing functions such as image registration, subtractions, measurements, 3d renderings, and reformats.Merge cadstream also includes user-configurable features for reporting on findings in breast or general mri studies.Additionally, merge cadstream assists users in planning mri guided interventional procedures.When interpreted by a skilled physician, this device provides information that may be used for screening, diagnosis, and interventional planning.Patient management decisions should not be made based solely on the results of merge cadstream.Merge cadstream may also be used as an image viewer of multi-modality, digital images, including ultrasound and mammography.Merge cadstream is not intended for primar interpretation of digital mammography images.On (b)(4) 2017, merge support was contacted by a user at the facility for assistance with correcting the patient positioning which was entered incorrectly at the modality.Cadstream is unable to edit the original image dicom data, as such, the processed study will reflect the incorrect patient positing on all post processing images.Study results having the potential to become part of the patients permanent record, and records have the potential to impact a patient's treatment, therefore there is a possibility for a misdiagnosis or mistreatment that could lead to harm.There is no indication that this issue as reported by the customer has resulted in any harm to a patient.Reference complaint number (b)(4).

• Brand Name: MERGE CADSTREAM
• Type of Device: IMAGING PROCESSING 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: meg mucha ; 900 walnut ridge drive; hartland, WI 53029 ; 2629123570
• MDR Report Key: 7156138
• MDR Text Key: 96233985
• Report Number: 2183926-2017-00213
• Device Sequence Number: 1
• Product Code: LLZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K092954
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Radiologic Technologist
• Type of Report: Initial
• Report Date: 12/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Radiologic Technologist
• Device Model Number: MERGE CADSTREAM V6.1.0.1010
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/01/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/13/2016
• 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