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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 Loss of Data (2903)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/17/2014
Event Type  malfunction  
Event Description
It was reported that labs results in flowsheet display descending dates view shows only latest imported results.There was no mistreatment reported based on the available information.
 
Manufacturer Narrative
The investigation was completed by conducting a thorough evaluation of the product.The issue was determined to be a defect in the product.The defect will be fixed in a later version.
 
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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 94086
Manufacturer (Section G)
IMPAC MEDICAL SYSTEMS,INC.
100 mathilda place, 5th floor
sunnyvale CA 94086
Manufacturer Contact
christopher ivicevich
100 mathilda place, 5th floor
sunnyvale, CA 94086
4088308023
MDR Report Key4252116
MDR Text Key5048259
Report Number2950347-2014-00031
Device Sequence Number1
Product Code IYE
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K141572
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Health Professional,User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 11/14/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/14/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Other Device ID Number2.60.257
Was Device Available for Evaluation? No
Date Manufacturer Received10/17/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/08/2014
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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