MAUDE Adverse Event Report: IMPAC MEDICAL SYSTEMS, INC. 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

The customer reported that the radiographers had to apply the toggle mlc button twice in mosaiq to get the leaves to return.Based on the available information there has been no actual mistreatment.

Manufacturer Narrative

Manufacturer's investigation results: the "toggle" in mosaiq is a simple "on/off".When selected, it performs an action (e.G open leaves) and then when selected again, performs the opposite action (close leaves).When the user retracts the leaves from the hand held controller the leaf positions are retracted.If the user then selects "toggle" from mosaiq, nothing happens.The customer is expecting the leaves to go to the planned values, but they need to "toggle" a second time for this to happen.This is not a safety issue because the retracted mlc leaf positions are clearly visible on the treatment control system (tcs) as well as in mosaiq.When the user "toggles" and expects the mlcs to move to the planned positions, and there is no movement, the user can clearly see this.It is the user's responsibility to review the treatment field before delivery.Mosaiq will deliver exactly what it displays.Mosaiq worked as designed and intended.

• 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.; 13723 riverport drive; suite 100; maryland heights MO 63043
• Manufacturer Contact: pms ; linac house; fleming way; crawley, west sussex RH10 -9RR ; UK RH10 9RR
• MDR Report Key: 6140603
• MDR Text Key: 61303162
• Report Number: 2950347-2016-00056
• Device Sequence Number: 1
• Product Code: IYE
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date: 03/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2016
• 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
• Date Manufacturer Received: 11/03/2016
• 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