MAUDE Adverse Event Report: IMPAC MEDICAL SYSTEMS, INC. MOSAIQ; ACCELERATOR, LINER, MEDICAL

Device Problems No Display/Image (1183); Programming Issue (3014); Data Problem (3196)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  No Answer Provided  

Event Description

It was reported that site setup window failed to appear and shifts were recorded incorrectly.There was no actual mistreatment base on the available information.Investigation is in progress to determine the cause.

• Brand Name: MOSAIQ
• Type of Device: ACCELERATOR, LINER, MEDICAL
• Manufacturer (Section D): IMPAC MEDICAL SYSTEMS, INC.; 100 mathilda place, 5th floor; sunnyvale CA 94086
• Manufacturer (Section G): IMPAC MEDICAL SYSTEMS, INC.; 100 mathilda place, 5th floor; sunnyvale CA 94086
• Manufacturer Contact: christopher ivicevich ; 100 mathilda place, 5th floor; sunnyvale, CA 94086 ; 4088308023
• MDR Report Key: 4135167
• MDR Text Key: 4949448
• Report Number: 2950347-2014-00028
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/26/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Other Device ID Number: VERSION 2.41.01JO
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/29/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/26/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1