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

Device Problem Inaccurate Delivery (2339)

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

Event Type  malfunction  

Event Description

It was reported that the total volume does not equal sum of agent volume for all drugs on the order.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 and 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 CA 94086
• Manufacturer Contact: linac house; fleming way; crawley, west sussex RH10 -9RR
• MDR Report Key: 4738897
• MDR Text Key: 5888972
• Report Number: 2950347-2015-00008
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2015
• 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
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/02/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/25/2015
• 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