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

Model Number ACUSON SC2000

Device Problem Device Operational Issue (2914)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/20/2018

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.(b)(4).

Event Description

It was reported that the physician observed an intermittent blue screens during a patients' stress echo test.The ultrasound system was rebooted; however, it was reported as not successful.The stress echo test was subsequently completed after the ultrasound system was repaired, but it was delayed by an unknown amount of time.There was no patient adverse event reported.No additional information was provided.

Manufacturer Narrative

This supplemental report is being submitted to provide the new date received by manufacturer (see date rec¿d by mfr); update the device available for evaluation (see concomitant medical products), provide the type of report; provide the type of reportable event (see type of reportable event); provide the type of follow-up (see if follow-up, what type); update the event problem and evaluation codes; and provide additional manufacturer narrative.In this case, the customer service engineer (cse) replaced the mbm board and reloaded the software.The mbm associated with the event was returned to the supplier, who performed tests on the unit.The supplier stated that the mbm board unit passed all tests, and the reported issue could not be reproduced by them.Review of the log files provided by the cse pointed to a hardware failure, however, since the returned unit passed all tests, the investigation results are inconclusive.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: 7371586
• MDR Text Key: 103804926
• Report Number: 3009498591-2018-00011
• 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: 10/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2018
• 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
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/11/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1