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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SIEMENS MEDICAL SOLUTIONS USA, INC. ACUSON; DIAGNOSTIC ULTRASOUND DEVICE
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SIEMENS MEDICAL SOLUTIONS USA, INC. ACUSON; DIAGNOSTIC ULTRASOUND DEVICE Back to Search Results
Model Number ACUSON SC2000
Device Problems Computer Software Problem (1112); Patient Data Problem (3197)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/14/2014
Event Type  malfunction  
Manufacturer Narrative
This report is resubmitted on request by the fda to correct initial report.If the first and second exams for the same patient id have the exact same spelling for patient name and the same upper/lower case characters, then the user will not get the pop-up to delete the first exam.This issue was fixed in a software release.
 
Event Description
When the physician registers the patient manually, an error message pops up stating that there is a mismatch between both patient information's and has to delete the other patient prior to starting the examination.Previously submitted.
 
Manufacturer Narrative
If the first and second exams for the same patient id have the exact same spelling for patient name and the same upper/lower case characters, then the user will not get the popup to delete the first exam.This issue was fixed in a software release.
 
Event Description
When the physician registers the patient manually, an error message pops up stating that there is a mismatch between both patient information's and has to delete the other patient prior to starting the examination.
 
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Brand Name
ACUSON
Type of Device
DIAGNOSTIC ULTRASOUND DEVICE
Manufacturer (Section D)
SIEMENS MEDICAL SOLUTIONS USA, INC.
mountain view CA 94043
Manufacturer Contact
karen smith, vp
685 east middlefield road
mountain view, CA 94043
8004228766
MDR Report Key5551131
MDR Text Key142665317
Report Number3009498591-2015-00102
Device Sequence Number1
Product Code IYN
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
072786
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Not Applicable
Remedial Action Modification/Adjustment
Type of Report Initial,Followup
Report Date 10/27/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/29/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberACUSON SC2000
Device Catalogue Number10433816
Was Device Available for Evaluation? Yes
Date Manufacturer Received10/27/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/01/2012
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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