MAUDE Adverse Event Report: DAVE KENNEDY - SENIOR QA MANAGER MOSAIQ; ACCELERATOR, LINEAR, MEDICAL

Device Problem Computer Software Problem (1112)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  No Answer Provided  

Manufacturer Narrative

The manufacturer's investigation is on-going and further information will be provided once the investigation has completed.

Event Description

It was reported that mosaiq is allowing treatment when the coach position is out of tolerance.Based on the available information, there was no mistreatment.

Manufacturer Narrative

During the investigation of this issue, elekta has tried to reproduce the issue.However this has not been possible.The site affected has undergone software, hardware and cable upgrades, and have not experienced this issue since.This case has been closed based on the fact that the issues is not reproducible and no further occurrences have been reported from the site.

• Brand Name: MOSAIQ
• Type of Device: ACCELERATOR, LINEAR, MEDICAL
• Manufacturer (Section D): DAVE KENNEDY - SENIOR QA MANAGER; impac medical systems, inc.; 100 mathilda place, 5th floor; sunnyvale CA 94086
• Manufacturer (Section G): DAVE KENNEDY - SENIOR QA MANAGER; impac medical systems, inc.; 100 mathilda place, 5th floor; sunnyvale CA 94086
• Manufacturer Contact: pms ; linac house; fleming way; crawley, RH10 -9RR ; UK RH10 9RR
• MDR Report Key: 5269976
• MDR Text Key: 32740206
• Report Number: 2950347-2015-00054
• Device Sequence Number: 1
• Product Code: IYE
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K141572
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Radiologic Technologist
• Type of Report: Initial,Followup
• Report Date: 06/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/09/2015
• Initial Date FDA Received: 12/07/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/19/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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