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

Model Number MERGE CADSTREAM 6.0.1.933

Device Problem Image Orientation Incorrect (1305)

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

Event Date 06/17/2016

Event Type  No Answer Provided  

Manufacturer Narrative

This issue, per information obtained by merge healthcare, indicates that there was a user error that originated on the mri modality.The customer contacted merge support for assistance in trying to minimize the issue with the incorrect laterality information due to orientation of the patient and settings at the modality.Additionally, 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 for viewing, analyzing, reporting, communicating and storing digital images derived from an mr image modality.Cadstream functionality includes recording, annotating, calculations, patient medication/interaction information, monitoring and tools to modify/enhance image and demographic information.On (b)(6) 2016, a customer reported to merge support indicating that there was a user that labeled images acquired during mri with the incorrect orientation via the mr scanner.I.E.Patient was put in the scanner feet first when it was expected that the head would have been put in first.Due to this error of patient positioning at the modality, the customer requested that merge support manually process the study and change the laterality to attempt to rectify the user error.This then causes the images to reflect a different laterality and anterior/posterior positioning embedded in the images versus what was originally taken by the modality.Due to study results having the potential to become part of the patients permanent record and records have the potential to impact a patient's treatment, 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: IMAGING PROCESSING SYSTEM
• Manufacturer (Section D): MERGE HEALTHCARE; 900 walnut ridge drive; harland WI 53029
• Manufacturer (Section G): MERGE HEALTHCARE; 900 walnut ridge rd; harland WI 53029
• Manufacturer Contact: mike diedrick ; 900 walnut ridge rd; hartland, WI 53029 ; 2629123570
• MDR Report Key: 5802140
• MDR Text Key: 49794074
• Report Number: 2183926-2016-00650
• 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: user facility
• Reporter Occupation: Radiologic Technologist
• Type of Report: Initial
• Report Date: 06/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MERGE CADSTREAM 6.0.1.933
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/17/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/31/2015
• 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