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

Device Problem Computer Operating System Problem (2898)

Patient Problem No Information (3190)

Event Type  malfunction  

Event Description

It was reported that if patient support angle is updated during site setup verification (by shift value being sent back from tcs), this new patient support angle is not sent back to the tcs when the user proceeds to vx port/treat.However, the update patient support angle is correctly displayed in the verified port and treat windows in mosaiq.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.

• 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 ; impac medical systems; 100 mathilda place, 5th floor; sunnyvale 94086 ; 4088308023
• MDR Report Key: 4348427
• MDR Text Key: 5203591
• Report Number: 2950347-2014-00038
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/19/2014

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: Other
• Other Device ID Number: VERSION 2.60
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/01/2014
• Initial Date FDA Received: 12/19/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/15/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1