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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SIEMENS MEDICAL SOLUTIONS USA, INC. PRIMUS HI; ACCELERATOR, LINEAR, MEDICAL
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SIEMENS MEDICAL SOLUTIONS USA, INC. PRIMUS HI; ACCELERATOR, LINEAR, MEDICAL Back to Search Results
Model Number 4504200
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Information (3190)
Event Date 11/27/2014
Event Type  malfunction  
Event Description
The customer informed siemens on (b)(6) 2014 that when the field size was checked, it was noticed that the y1 jaw is too small.The y1 jaw displays 5 cm and field size 4.5 cm.Only after the on/off switch was engaged, the display and field size matched, again.There is no report of injury to a patient.This reported issue occurred in (b)(6).
 
Manufacturer Narrative
Siemens became aware of the reported issue on november 27, 2014.This mdr is being mailed on december 26, 2014.The investigation in on-going and a supplemental report will be submitted upon completion.(b)(4).
 
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Brand Name
PRIMUS HI
Type of Device
ACCELERATOR, LINEAR, MEDICAL
Manufacturer (Section D)
SIEMENS MEDICAL SOLUTIONS USA, INC.
4040 nelson ave.
concord CA 94520
Manufacturer (Section G)
SIEMENS MEDICAL SOLUTIONS USA, INC.
4040 nelson ave.
concord CA 94520
Manufacturer Contact
marlynne galloway
51 valley stream parkway, ms - d02
malvern, PA 19355
6102195361
MDR Report Key4390480
MDR Text Key5430245
Report Number2910081-2014-09340
Device Sequence Number1
Product Code IYE
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K993425
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility,Company Representative
Reporter Occupation Not Applicable
Type of Report Initial
Report Date 12/26/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/29/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number4504200
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received11/27/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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