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

Device Problem Computer Software Problem (1112)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)

Event Type  malfunction  

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 couch values were incorrect after mosaiq had been upgraded.Some treatments were delivered before the errors had been corrected.Based on the available information there has been actual mistreatment.

Manufacturer Narrative

Report type updated to include product problem.Type of reportable event added malfunction.Investigation results - additional information: the manufacturer's investigation analysis found that following an upgrade to mosaiq the table rotations were not correctly configured in the ".Mac" file (direction of increase set as cw for ccw or visa versa).Four patients were treated until the error was realised.Elekta physics have reviewed the available data and conclude that presumably that the location of the isocenter could still be established for which a total miss of the target was not likely.However with incorrect rotation it is likely that the periphery of the target could have been shifted outside the treatment field, and that oars may have been shifted into the treatment field.The appropriate machine characterisation has been set and the reported problem no longer occurs.The mac templates were also changed to address this in the future.

• 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, RH10 -9RR ; UK RH10 9RR
• MDR Report Key: 6197992
• MDR Text Key: 63072182
• Report Number: 2950347-2016-00059
• Device Sequence Number: 1
• Product Code: IYE
• UDI-Device Identifier: 00858164002091
• UDI-Public: 00858164002091
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 05/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/28/2016
• 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
• Patient Outcome(s): Other