MAUDE Adverse Event Report: CHRISTOPHER IVICEVICH - DIRECTOR OF RA/QA MOSAIQ; ACCELERATOR, LINEAR, MEDICAL

Device Problems Computer Software Problem (1112); Display or Visual Feedback Problem (1184)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

It was reported that when using the source characterization on 601 scaled machines, any planned collimator value that is invalid (1-179) is flipped at import instead of being flagged as invalid.A collimator angle of 1 degree becomes 181 degrees for example.This only occurs when a cw or ccw range is set.For example, most cw is 180 and most ccw is 0.There was no mistreatment.This issue was found internally.

Manufacturer Narrative

The investigation was completed by conducting a thorough evaluation of the product.The issue was determined to be a defect in the product.This defect will be fixed in a later version.

Manufacturer Narrative

(b)(4).Upon further investigation by the manufacturer it was found that not only was the collimator flipped but the jaws and the mlc shape are flipped as well.Mosaiq is taking a plan with an invalid collimator angle and modifying it to achieve a valid field.There is legacy code in mosaiq (mlc flip) that is evoked to manage this.Four different fields were tested with invalid collimator angles and mlc shapes and in all cases, the resultant "flip" retained the correct mlc shape.Mosaiq is working as designed and intended.This is not a defect and not a safety issue as previously reported.

• Brand Name: MOSAIQ
• Type of Device: ACCELERATOR, LINEAR, MEDICAL
• Manufacturer (Section D): CHRISTOPHER IVICEVICH - DIRECTOR OF RA/QA; impac medical systems,inc.; 100 mathilda place, 5th floor; sunnyvale 94086
• Manufacturer (Section G): CHRISTOPHER IVICEVICH - DIRECTOR OF RA/QA; impac medical systems,inc.; 100 mathilda place, 5th floor; sunnyvale 94086
• Manufacturer Contact: christopher ivicevich ; linac house; fleming way; crawley, west sussex RH10 -9RR ; UK RH10 9RR ; 4088308023
• MDR Report Key: 4252099
• MDR Text Key: 15913774
• Report Number: 2950347-2014-00033
• Device Sequence Number: 1
• Product Code: IYE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123230
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Other Device ID Number: 2.50
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/12/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/06/2012
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1