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

Model Number ACUSON SC2000

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/28/2015

Event Type  malfunction  

Manufacturer Narrative

The device referenced in this report was not returned to siemens for evaluation; however, the system log files were captured and analyzed.During the analysis, it was confirmed that the event was a check-in failure where the patient's file was not saving correctly at the conclusion of an exam.The root cause was determined to be a software bug and the reason for failure is that the oracle database still had the original patient name information in the lookup tables even thought the exam data had been deleted.The issue was resolved in software updates (16 dec 2015), vb10d (03 jun 2016), and vb20a (17 apr 2017).(b)(4).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.There was a fsca for all sc2000 customers in 2015 (fda # z-2783-2015).

Event Description

It was reported that during an unspecified exam, the ultrasound system gave an error regarding sr data.There was no report of patient adverse event.No additional information was provided.

• 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
• Manufacturer Contact: scott christiansen ; 685 east middlefield road; mountain view, CA 94043-4050 ; 4252709862
• MDR Report Key: 7597598
• MDR Text Key: 111451005
• Report Number: 3009498591-2018-00026
• 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
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 06/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2018
• 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?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/28/2015
• 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
• Removal/Correction Number: 300949859110072015009C
• Patient Sequence Number: 1