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

Model Number ACUSON SC2000

Device Problem Computer Software Problem (1112)

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

Event Date 09/05/2014

Event Type  malfunction  

Manufacturer Narrative

Steering angle is being incorrectly restored in 3.5 from 2.0 and 3.0 9l4 preset backups.This can result in non-zero steering for color and spectral doppler on non-linear probes.The 9l4 and 6c1 hd not affected.Backup datasets that have been created on 2.0 or 3.0 on nonlinear transducers (when user switched to a nonlinear transducer from linear steered image and saved preset) would exhibit the problem when they are restored to 3.5 release because the color doppler image would be steered.Factors that currently mitigate the risk of the hazard: this issue only affects sites that use the 9lr linear probe prior to 3.5.Workaround: if the user deletes the restored user defined presets and manually creates them, the problem is not observed.In addition, the user may switch to the factory default preset.The user will not experience this issue with factory default presets.It is only seen with user defined presets.

Event Description

After upgrading a va30a or va30b system to va35a, and restoring all system backups, color flow outside of the expected area when using the restored user defined presets was observed.This is a color misregistration issue with user-defined presets.The use of the 9l4 transducer on the 2.0 and 3.0 releases can cause color misregistration on non-linear probes in the 3.5 release.

• 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 Key: 5485678
• MDR Text Key: 39978454
• Report Number: 3009498591-2015-00093
• Device Sequence Number: 1
• Product Code: ITX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: 072786
• Number of Events Reported: 1
• 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: 09/05/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2015
• 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
• Other Device ID Number: 10433816
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/05/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1