MAUDE Adverse Event Report: SIEMENS MEDICAL SOLUTIONS USA INC. ACUSON; DIAGNOSTIC ULTRASOUND DEVICE

Model Number ACUSON SC2000

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/24/2014

Event Type  malfunction  

Event Description

While scanning a carotid exam, a user placed a pulsed wavegate within a stenosis in the external carotid artery.She increased the pw prf to 13,021 (slightly above 300cm/s).The auto-stat measurement caliper is appropriately placed (near 300 cm/s) but the displayed measurement of the peak systole velocity is 101.5 cm/s.This issue is reproducable in all exams (except cardiac) by changing multihz or baseline or scale with auto-stats enabled.On freeze, the velocity will display from the precious scale.All values in the mda will be incorrect, another scenario is to use velocity tool on a live image and change multihz, the value does not update in this case.

Manufacturer Narrative

This issue was introduced when we fixed us_00113852 ((b)(4)) / us_00114716 ((b)(4)); "measurement value changes in the report when baseline is changed".We removed the dependence on some parameter updates im order to fix those issues.

• 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, regulatory aff ; 685 east middlefield road; mountain view, CA 94043 ; 8004228766
• MDR Report Key: 3944632
• MDR Text Key: 21525524
• Report Number: 3009498591-2014-00017
• Device Sequence Number: 1
• Product Code: IYN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: 131164
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 05/02/2014

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 Number: ACUSON SC2000
• Device Catalogue Number: 10433816
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/27/2014
• Initial Date FDA Received: 05/05/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1