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

Model Number ACUSON SC2000

Device Problem Loss of Data (2903)

Patient Problem No Information (3190)

Event Date 06/05/2018

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 and investigated at a later date, this report will be supplemented.

Event Description

It was reported that while troubleshooting the ultrasound system due to intermittent lock ups and requiring hard reboots, the user discovered that 3 of 4 patient exams were missing.Hard reboots is removing the power with the software still running.No additional information was provided.Multiple attempts were made via email to obtain patient outcome and additional information regarding the reported phenomenon but with no results.

Manufacturer Narrative

This supplemental report is being submitted to provide the date new information was received and provide the type of report.The device referenced in this report was not returned to siemens for evaluation; however, the savelogs were captured and investigated.During the investigation, it was found that the database was extensively used as it was discovered that approximately (b)(6) of data were stored in the data repository.Based on the information gathered from the review of the savelogs, the probable cause and the likely factor of the reported intermittent lock ups and loss of patients' exams was determined to be the heavy disk load which occupied a significant portion on the hard drive.This likely contributed to the system performance degradation and/or abrupt shutdown.The ultrasound system shall be primarily used to store data for short time but not for permanent store because it is not designed to hold months of data for thousands of patients.Per the instructions for use (ifu): "siemens recommends you archive data, including images and clips, to a network or an external recording medium, such as a cd/dvd, usb, or dicom storage device." (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
• MDR Report Key: 7723505
• MDR Text Key: 115397669
• Report Number: 3009498591-2018-00033
• Device Sequence Number: 1
• Product Code: IYN
• Combination Product (y/n): N
• PMA/PMN Number: K113179
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 11/28/2018

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
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/28/2018
• Initial Date FDA Received: 07/26/2018
• Supplement Dates Manufacturer Received: 11/26/2018
• Supplement Dates FDA Received: 11/28/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1