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

Model Number ACUSON SC2000

Device Problems Loss of Data (2903); Device Operational Issue (2914)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/09/2015

Event Type  malfunction  

Manufacturer Narrative

The device referenced in this report was not returned to siemens for evaluation; however, the ultrasound system savelogs were captured and reviewed.During the review, it was found that the software was not storing images due to "check-in" failures.It means that when submitting patient information identical to an existing patient, except for case differences in the patient name, a software bug will prevent the images to be stored.The image storing issue was resolved in software updates va35e (released 7 october 2015), vb10d (released 10 june 2016), and vb20a (released 17 april 2017).Reference: (b)(4).

Event Description

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).It was reported that it was not possible to store clips in the ultrasound system.There was no patient adverse event reported.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: 7566553
• MDR Text Key: 110054570
• Report Number: 3009498591-2018-00020
• Device Sequence Number: 1
• Product Code: IYO
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K113179
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 06/04/2018

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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/13/2015
• Initial Date FDA Received: 06/04/2018
• 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