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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SIEMENS MEDICAL SOLUTIONS ISA, INC. ACUSON SC2000 ULTRASOUND SYSTEM; DIAGNOSTIC ULTRASOUND DEVICE
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SIEMENS MEDICAL SOLUTIONS ISA, INC. ACUSON SC2000 ULTRASOUND SYSTEM; DIAGNOSTIC ULTRASOUND DEVICE Back to Search Results
Model Number ACUSON SC2000
Device Problems Defective Device (2588); Device Displays Incorrect Message (2591); Loss of Data (2903); Data Problem (3196)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Date 12/08/2014
Event Type  malfunction  
Event Description
It was reported that during an unspecified exam, the ultrasound system repeatedly produced a "clip cancelled" error messages with each capture.There was no patient adverse event reported.No additional information was provided.Previously submitted.
 
Manufacturer Narrative
When patient name, patient id, patient date of birth, and the patient gender match, the system works as expected.In the case of the patient's name having a difference in upper/lower case from the original generation of this patient, the sw is not correctly accounting for this difference.The system sees this as two patients with 3 of 4 identifiers matching, and does not allow the capture of clips/images.This will be resolved via software release.
 
Event Description
Customer stated that they lost a patient exam and had to repeat it.
 
Manufacturer Narrative
The device referenced in this report was not returned to siemens for evaluation; however, the system log files were captured and reviewed.During the review, it was found that the software was not storing images due to "check-in" failures.When submitting patient information identical to an existing patient, except for case differences in the patient name, a software bug will not allow storing of images.The image storing issue was resolved in software updates va35e (released 7 october 2015), vb10d (released 10 june 2016), and vb20a (released 17 april 2017).
 
Event Description
It was reported that during an unspecified exam, the ultrasound system repeatedly produced a "clip cancelled" error messages with each capture.There was no patient adverse event reported.No additional information was provided.
 
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Brand Name
ACUSON SC2000 ULTRASOUND SYSTEM
Type of Device
DIAGNOSTIC ULTRASOUND DEVICE
Manufacturer (Section D)
SIEMENS MEDICAL SOLUTIONS ISA, INC.
685 east middlefield road
mountain view CA 94043
MDR Report Key5551139
MDR Text Key142667526
Report Number3009498591-2015-00104
Device Sequence Number1
Product Code IYO
Combination Product (y/n)N
PMA/PMN Number
K113179
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Remedial Action Modification/Adjustment
Type of Report Initial,Followup,Followup
Report Date 06/01/2018
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? No
Was the Report Sent to FDA? No
Date Manufacturer Received04/17/2018
Patient Sequence Number1
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