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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 Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
The investigation was completed by conducting a thorough evaluation of the product and the reported information.The issue was determined to be a defect in the product.The defect will be monitored and re-evaluated based on the post market data.
 
Event Description
The customer reported that when: adjusting the changed dose does not propagate for the order for the rest of the care plan, it only changes the order for the window that opened.Based on the available information, there has been no actual mistreatment.
 
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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 Key6131248
MDR Text Key60993171
Report Number2950347-2016-00054
Device Sequence Number1
Product Code IYE
UDI-Device Identifier00858164002091
UDI-Public00858164002091
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K141572
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,o
Reporter Occupation Other
Type of Report Initial
Report Date 11/29/2016
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? Yes
Device Operator Health Professional
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 11/02/2016
Initial Date FDA Received11/29/2016
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 Number1
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