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

Model Number ACUSON SC2000

Device Problem Computer Software Problem (1112)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/25/2018

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.This initial mdr was originally submitted on 24 july 2018, with all three fda esg confirmations showing that the submission was received and passed acceptance on 24 july 2018.The report is being resubmitted on request by the fda, due to a defect in the fda systems at that time.This report is identical to the previous initial mdr submission, except for updates to the available selections in the submitter software since the original submission, and updates to the available event problem and evaluation codes.

Event Description

It was reported that different unknown studies performed on the ultrasound system were lost due to software corruption.Reportedly, it was not possible to see the patients images because the patient list was disabled.The reported event was discovered during patient planning; therefore, there was no procedure being performed at the time.There was no patient adverse event reported when the ultrasound system was previously used during the unknown studies.No additional information was provided.

Manufacturer Narrative

This supplemental report is being submitted to provide the date new information was received; provide the type of report; provide the type of reportable event and the type of follow-up; update the event problem and evaluation codes; and provide additional manufacturer narrative.The device was not returned to siemens for evaluation; however, the savelogs were captured.Investigation reviewed the logs and was unable to confirm that the reported event was caused by abrupt shutdown.It was determined that the probable cause was a hardware issue with the hard drive.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
• MDR Report Key: 8106852
• MDR Text Key: 142493157
• Report Number: 3009498591-2018-00032
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 11/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/27/2018
• 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?: No
• Date Manufacturer Received: 11/20/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1