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

Device Problem Device Slipped (1584)

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

Event Date 04/06/2015

Event Type  No Answer Provided  

Event Description

It was reported that the shifts were sent over to mosaiq and performed using couch move assistant.After the table moved, the therapist checked the shifts and the table was not position correctly.The table had shifted over 16 cm laterally and several cm in the other two directions.The couch positions at this point were not recorded, but the therapist believed that the lateral couch position (which was at -16.3 prior to the cbct) was at 0.2 after shifting with the couch move assistant.There was no mistreatment reported based on the available information.The patient was setup again to their marks, a new cbct was performed, the image was registered, the shifts were sent to mosaiq and performed correctly using couch move assistant and the patient was treated with the correct setup.

Manufacturer Narrative

The investigation was completed by conducting a thorough evaluation of the product and the reported information.The issue could not be confirmed and cause could not be determined based on the available information.

• Brand Name: MOSAIQ
• Type of Device: ACCELERATOR, LINEAR, 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 94086 ; 4088308023
• MDR Report Key: 4754060
• MDR Text Key: 5822199
• Report Number: 2950347-2015-00009
• 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: 05/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Other
• Other Device ID Number: VERSION 2.41
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/06/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/23/2012
• 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