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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SIEMENS MEDICLA SOLUTIONS USA, INC. ACUSON; DIAGNOSTIC ULTRASOUND DEVICE
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SIEMENS MEDICLA SOLUTIONS USA, INC. ACUSON; DIAGNOSTIC ULTRASOUND DEVICE Back to Search Results
Model Number ACUSON SC2000
Device Problems Break (1069); Crack (1135); Unstable (1667); Material Integrity Problem (2978)
Patient Problem No Information (3190)
Event Date 04/02/2014
Event Type  malfunction  
Event Description
The sc2000's upper assembly is supported by an "arm." this arm is comprised of an upper and lower half.It has been reported the lower half can crack or break all the way through.When this occurs, the integrity of the design is compromised, causing instability.
 
Manufacturer Narrative
A follow up report will be submitted when the investigation has been completed.
 
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Brand Name
ACUSON
Type of Device
DIAGNOSTIC ULTRASOUND DEVICE
Manufacturer (Section D)
SIEMENS MEDICLA SOLUTIONS USA, INC.
mountain view CA 94043
Manufacturer Contact
karen smith, vp
685 east middlefield road
mountain view, CA 94043
004228766
MDR Report Key3829697
MDR Text Key4403008
Report Number3009498591-2014-00020
Device Sequence Number1
Product Code ITX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
123622
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility,Company Representative
Reporter Occupation Not Applicable
Type of Report Initial
Report Date 05/07/2014
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
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 04/02/2014
Initial Date FDA Received05/07/2014
Was Device Evaluated by Manufacturer? No
Date Device Manufactured02/01/2010
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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