Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SIEMENS MEDICAL SOLUTIONS USA INC. ACUSON; DIAGNOSTIC ULTRASOUND DEVICE
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

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 04/08/2014
Event Type  malfunction  
Manufacturer Narrative
The device that locks the swivel when you release the trigger can become un-mounted.This means that when you release the trigger, the control panel left to right swivel action is not stopped.The locking mechanism design was changed to prevent this from occurring.
 
Event Description
When the pivot at which the control panel steers the system becomes increasingly loose, it is more difficult to steer the product.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key5485626
MDR Text Key39979301
Report Number3009498591-2015-00073
Device Sequence Number1
Product Code IYN
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
072786
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Reporter Occupation Not Applicable
Remedial Action Modification/Adjustment
Type of Report Initial
Report Date 04/09/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/26/2015
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
Is the Reporter a Health Professional? No
Date Manufacturer Received04/09/2014
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
Removal/Correction Number3009498591-01-02-2024-00
Patient Sequence Number1
-
-