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

Device Problems No Display/Image (1183); Device Operates Differently Than Expected (2913)

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

Event Type  malfunction  

Event Description

It was reported that the medication administered is not showing up on mar, e.G.Medication for patient was given.Status of the order was changed to completed but it does not show up in the mar.There was no report of mistreatment based on the available information.

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 was 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: 4348429
• MDR Text Key: 5143765
• Report Number: 2950347-2014-00039
• 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,Health Professional,User Facility
• 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

• Date FDA Received: 12/19/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Other Device ID Number: VERSION 2.30.4.D1SP10
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/19/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/14/2012
• 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