MAUDE Adverse Event Report: MERGE HEALTHCARE ORTHOCASE; MEDICAL IMAGE PROCESSING SOFTWARE.

Model Number 3.7.3

Device Problems Computer Software Problem (1112); Incorrect Measurement (1383)

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

Event Date 10/02/2015

Event Type  malfunction  

Manufacturer Narrative

Upon retrospective review, this issue was determined to be reportable as an mdr.

Event Description

A merge orthocase customer reported that the displayed value of the measurement is changing after saving a plan with a measurement result.When using the perpendicular line tool, there is an option to "snap" the lines together, which prevents the perpendicular lines from extending past the straight/base line.The system default is to snap these lines.To remove the snapping function from the current annotation, simply right click near the line and deselect "snap to." while the system default is set to snap the lines together, the actual "snap" function may not occur until the plan is saved, at which time the line end point within 20 pixels of the base line will adjust its location to snap perfectly to the base line.This may adjust the length and corresponding measurement of the perpendicular line when the plan is reopened.(b)(4).

Manufacturer Narrative

Submitting this supplemental report to add fda correction and removal reference numbers.

• Brand Name: ORTHOCASE
• Type of Device: MEDICAL IMAGE PROCESSING SOFTWARE.
• 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 rd; hartland, WI 53029 ; 2629123570
• MDR Report Key: 5437883
• MDR Text Key: 38224512
• Report Number: 2183926-2015-00127
• Device Sequence Number: 1
• Product Code: LLZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K022881
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Health Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 02/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3.7.3
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/02/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/04/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: Z-0878-2017; RES 75909
• Patient Sequence Number: 1