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

Model Number ACUSON SC2000

Device Problem Loss of Data (2903)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/17/2015

Event Type  malfunction  

Manufacturer Narrative

While preparing for an internal audit, complaints that were evaluated as part of a health risk evaluation were reviewed for alignment to the corrective actions that were taken.The complaints were filed per 21 cfr 803.In reviewing these complaints it was discovered that other complaints were missed in regards to mdr reporting.These complaints are now being submitted as mdrs.The device referenced in this report was not returned to siemens for investigation; however, the systems' save log was reviewed.It was found that the data loss was due to system lock ups caused by insufficient power to the usb port.This issue was fixed with a design change to the sc2000 control panel (cp), implemented on 8 november 2017.(b)(4).

Event Description

It was reported that the ultrasound system went to blue screen and the user had to reboot three times.All images were lost.There was no report of patient adverse event.No additional information was provided.

• Brand Name: ACUSON SC2000 ULTRASOUND SYSTEM
• Type of Device: DIAGNOSTIC DEVIDE
• Manufacturer (Section D): SIEMENS MEDICAL SOLUTIONS USA, INC.; 685 east middlefield road; mountain view CA 94043 4050
• Manufacturer Contact: christine dunn ; 685 east middlefield road; mountain view, CA 94043-4050 ; 4255571625
• MDR Report Key: 7880887
• MDR Text Key: 120536085
• Report Number: 3009498591-2018-00039
• 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,user f
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2018
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/17/2015
• 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