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

Model Number 6.2.2.1184

Device Problem Use of Device Problem (1670)

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

Event Date 03/19/2020

Event Type  malfunction  

Manufacturer Narrative

The issue, incorrect patient orientation on all study images, was caused by incorrect data entry at the mr scanner.This is not an issue or malfunction that was caused or contributed to by the merge cadstream medical device.The root cause is due to an error by a technician at the scanner or imaging device.There have been no reports of injury or impact to a patient as a result of this issue.No further actions are anticipated at this time.

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) 2020, merge technical support was contacted by a user at a facility for assistance with correcting a study with incorrect patient orientation.The patient's orientation was entered incorrectly at the scanner.Cadstream is prohibited, per design, from editing or modifying image dicom data, including patient orientation and laterality of image data as received from other application entities.Patient images and study results have the potential to become part of the patient's permanent record and those records have the potential to impact a patient's treatment.There is a possibility for a misdiagnosis or mistreatment that could lead to harm due to the incorrect patient orientation as displayed in cadstream.However, 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
• Manufacturer (Section G): MERGE HEALTHCARE; 900 walnut ridge drive; hartland, wi
• Manufacturer Contact: brian bell ; 75 binney st; cambridge, ma ; 3540189
• MDR Report Key: 9964220
• MDR Text Key: 200827475
• Report Number: 2183926-2020-00014
• 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: 03/19/2020

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: 6.2.2.1184
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/19/2020
• Initial Date FDA Received: 04/15/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/17/2018
• 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