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U.S. Department of Health and Human Services

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

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IMPAC MEDICAL SYSTEMS, INC. MOSAIQ; ACCELERATOR, LINEAR, MEDICAL Back to Search Results
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.
 
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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 Key6140603
MDR Text Key61303162
Report Number2950347-2016-00056
Device Sequence Number1
Product Code IYE
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K141572
Number of Events Reported1
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
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 11/03/2016
Initial Date FDA Received12/02/2016
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received03/21/2017
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 Number1
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