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 Consequences Or Impact To Patient (2199)

Event Date 07/13/2018

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 after a (b)(6)-year old male patient underwent a transesophageal echocardiography (tee) procedure, the ultrasound system was transferred to another department.When the system was being powered up to transfer the images, the system was reported to have crashed and the images were lost and were unrecoverable.Since the tee was a pre-op procedure, the doctor did not repeat the tee; however, the patient will undergo another tee intra-op.This is the hospitals' standard protocol.There was no patient adverse event reported.No additional information was provided.

Manufacturer Narrative

This supplemental report is being submitted to provide the date new information was received and provide the type of report; provide the type of reportable event, provide the type of follow-up, and update the patient problem and evaluation codes; and provide additional manufacturer narrative.The device referenced in this report was not returned to siemens for investigation; hence, no device evaluation could be performed.The customer service engineer (cse) reinstalled the software but was not able to create a savelog before the hdd was overwritten.Therefore, no analysis could be done for root cause determination.It was further stated that as evidenced by cse - noting that "windows recovery " screen was seen during the attempted boots, it is likely that the cause of boot issue was windows file system corruption.It was confirmed that ip change did not contribute to the boot issue, but it is the reason that the exam was not transferred to the pacs system before the event and why the exam was lost.The probable cause of the windows file system corruption could be due to an abrupt improper system power down by the user.The user should perform shut down of the system according to the instructions for use (ifu).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: 7724321
• MDR Text Key: 115372795
• Report Number: 3009498591-2018-00034
• 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,health
• 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: 07/13/2018
• 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
• Patient Age: 78 YR
• Patient Weight: 70