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 08/15/2014

Event Type  malfunction  

Manufacturer Narrative

There is a sw issue when the system preset for aux capture is enabled and the system attempts to automatically switch to aux vs ecg capture, the r-wave triggered capture does not work.The issue was fixed in a software release.

Event Description

When the stress echo preset is selected using aux input for the ecg, the stress echo imaging screen will display an good ecg (orange-aux signal) waveform, but in capture review the ecg (green) will be flat or not there between the waveform flag markers and the capture will have reverted to time-based capture in seconds.This occurs intermittently.This can also occur in non-stress echo studies.

• 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: 5485684
• MDR Text Key: 39978523
• Report Number: 3009498591-2015-00098
• Device Sequence Number: 1
• Product Code: ITX
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: 072786
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Not Applicable
• Remedial Action: Modification/Adjustment
• Type of Report: Initial
• Report Date: 10/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2015
• 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?: Yes
• Date Manufacturer Received: 10/03/2014
• 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