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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SIEMENS MEDICAL SOLUTIONS USA, INC. ACUSON SC2000 ULTRASOUND SYSTEM; ULTRASOUND DEVICE

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SIEMENS MEDICAL SOLUTIONS USA, INC. ACUSON SC2000 ULTRASOUND SYSTEM; ULTRASOUND DEVICE Back to Search Results
Model Number ACUSON SC2000
Device Problems Loss of Data (2903); Device Operational Issue (2914)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/09/2015
Event Type  malfunction  
Manufacturer Narrative
The device referenced in this report was not returned to siemens for evaluation; however, the ultrasound system savelogs were captured and reviewed.During the review, it was found that the software was not storing images due to "check-in" failures.It means that when submitting patient information identical to an existing patient, except for case differences in the patient name, a software bug will prevent the images to be stored.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).Reference: (b)(4).
 
Event Description
While preparing for an internal audit, complaints that were evaluated as part of a health risk evaluation were reviewed for alignment to the corrective actions that were taken.The complaints were filed per 21 cfr 803.In reviewing these complaints, it was discovered that other complaints were missed in regards to mdr reporting.These complaints are now being submitted as mdrs.There was a fsca for all sc2000 customers in 2015 (fda # z-2783-2015).It was reported that it was not possible to store clips in the ultrasound system.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
ULTRASOUND DEVICE
Manufacturer (Section D)
SIEMENS MEDICAL SOLUTIONS USA, INC.
685 east middlefield road
mountain view CA 94043 4050
Manufacturer Contact
scott christiansen
685 east middlefield road
mountain view, CA 94043-4050
4252709862
MDR Report Key7566553
MDR Text Key110054570
Report Number3009498591-2018-00020
Device Sequence Number1
Product Code IYO
Combination Product (y/n)N
Reporter Country CodeSZ
PMA/PMN Number
K113179
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Physician
Remedial Action Recall
Type of Report Initial
Report Date 06/04/2018
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
Device Model NumberACUSON SC2000
Device Catalogue Number10433816
Device Lot NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 04/13/2015
Initial Date FDA Received06/04/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Removal/Correction Number300949859110072015009C
Patient Sequence Number1
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