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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 Problem Split (2537)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/09/2014
Event Type  malfunction  
Event Description
The bolts that secure the uilk assembly to the uic column have sheared.This has allowed the uilk arm to move and become unstable.No consequences to the patient or user were reported.
 
Manufacturer Narrative
The bolt is failing only on units reworked with the newer insert and bolt.The current commercial shoulder bolt design passed testing to 200 pounds force at system handles.
 
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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
business unit ultrasound
mountain view, CA 94043
8004228766
MDR Report Key4286292
MDR Text Key15329473
Report Number3009498591-2014-00040
Device Sequence Number1
Product Code IYN
Combination Product (y/n)N
Reporter Country CodeAU
PMA/PMN Number
131164
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility,Company Representative
Reporter Occupation Not Applicable
Remedial Action Repair
Type of Report Initial
Report Date 11/14/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/14/2014
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
Other Device ID Number10433816
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Date Manufacturer Received11/10/2014
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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