MAUDE Adverse Event Report: SIEMENS MEDICAL SOLUTIONS USA, INC. ACUSON SC2000 ULTRASOUND SYSTEM; ULTRASOUND DEVICE

Model Number ACUSON SC2000

Device Problems Computer Software Problem (1112); Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Patient Involvement (2645)

Event Date 02/01/2018

Event Type  malfunction  

Manufacturer Narrative

The device referenced in this report has not been returned to siemens for evaluation.If additional information is received or if the device is returned at a later date, this report will be supplemented.

Event Description

It was reported that during an in-house study/testing using previously acquired images, it was found that the values of the vvi (velocity vector imaging) for edv (end diastolic volume) and esv (end systolic volume) for the la (left atrium) were incorrect.Accordingly, the vvi did not report the correct volumes and the differences in values were noted between two approaches in terms of the relationship between vvi la edv and la esv versus esie lh la edv and la esv.There was no patient involved during the study.No additional information was provided.

Manufacturer Narrative

This supplemental report is being submitted to provide the new date received by manufacturer.This issue was investigated and it was found the root cause was a software coding issue, which switched values of the numerator and the denominator.Therefore, it was a very obvious numerical error, which would not cause any misinterpretation of the values.For this complaint, when it was originally received on (b)(6) 2018, it was classified as a safety issue.Based on the information available at the time, this complaint was identified as potentially leading to misdiagnosis and therefore, it was decided to file an 803 report.However, the investigation confirmed that the switched la edv and la esv values would not be clinical viable data, and thus, would not cause or contribute to misdiagnosis of the patient, and thereby, to any patient harm.Based on these findings, this supplemental mdr is to correct the previously submitted report.Reference complaint # (b)(4).

• Brand Name: ACUSON SC2000 ULTRASOUND SYSTEM
• Type of Device: ULTRASOUND DEVICE
• Manufacturer (Section D): SIEMENS MEDICAL SOLUTIONS USA, INC.; 685 east middlefield road; mountain view CA 94043 4050
• Manufacturer Contact: scott christiansen ; 685 east middlefield road; mountain view, CA 94043-4050 ; 4252709862
• MDR Report Key: 7286838
• MDR Text Key: 100898421
• Report Number: 3009498591-2018-00007
• Device Sequence Number: 1
• Product Code: IYN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113179
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,study
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date: 06/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Medical Equipment Company Technician/Representative
• Device Model Number: ACUSON SC2000
• Device Catalogue Number: 10433816
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/19/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1