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

Model Number CADSTREAM V5.0.7.1110

Device Problem Improper or Incorrect Procedure or Method (2017)

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

Event Date 09/20/2018

Event Type  malfunction  

Manufacturer Narrative

The issue, study reflects incorrect patient orientation on all images, was caused by incorrect data entry at the scanner.

Event Description

Cadstream is intended to be used in the visualization, analysis, and reporting of magnetic resonance imaging (mri) studies.Cadstream supports evaluation of dynamic mr data acquired during contrast administration.Cadstream performs other user selected processing functions (such as image registration, subtractions, measurements, 3d renderings, and reformats).On (b)(6) 2018, merge technical support was contacted by a user at the facility for assistance with correcting the patient orientation, which was entered incorrectly at the mr scanner.Support suggested adjustments could be made to the study to improve accuracy, however, the orientation would remain incorrect.Cadstream is prohibited from editing or modifying image dicom data, including patient orientation and laterality, received from other application entities.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.(b)(4).

• Brand Name: MERGE CADSTREAM
• Type of Device: IMAGE PROCESSING SYSTEM
• Manufacturer (Section D): MERGE HEALTHCARE; 900 walnut creek dr; hartland WI 53029
• Manufacturer (Section G): MERGE HEALTHCARE; 900 walnut creek sr; hartland WI 53029
• Manufacturer Contact: meg mucha ; 900 walnut creek dr; hartland, WI 53029 ; 2629123570
• MDR Report Key: 7987792
• MDR Text Key: 125435585
• Report Number: 2183926-2018-00087
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CADSTREAM V5.0.7.1110
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/20/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/31/2009
• 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