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

Device Problem Display or Visual Feedback Problem (1184)

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

Event Type  No Answer Provided  

Event Description

It was reported that there are issues with the prn orders and the due date.The due date is on the (b)(6) 2014 for all treatments but the cycle and day are different.When looking at the cws, the orders are in the right place on the right day, right cycle.There was no report of mistreatment based on the available information.

Manufacturer Narrative

Investigation is in progress to determine the cause.

Manufacturer Narrative

The investigation was completed by conducting a thorough evaluation of the information provided from the customer and the product.Cause could not be determined as the issue could not be reproduced.

• 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 94086-RH10 ; UK 94086RH10 ; 4088308023
• MDR Report Key: 4338806
• MDR Text Key: 5203358
• Report Number: 2950347-2014-00037
• Device Sequence Number: 1
• Product Code: IYE
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K123230
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/01/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Other Device ID Number: VERSION 2.41.01H5
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/17/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/10/2012
• 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