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

Model Number ACUSON SC2000

Device Problems No Display/Image (1183); Device Operational Issue (2914)

Patient Problem No Information (3190)

Event Date 02/07/2018

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/evaluated at a later date, this report will be supplemented.(b)(4).

Event Description

It was reported that at the beginning and during an unspecified diagnostic procedure, the ultrasound system intermittently lost the echocardiogram (ecg) trace.The user rebooted the system and the issue was resolved.No additional information was provided.Multiple attempts were made via email to obtain additional information and patient outcome but with no results.

Manufacturer Narrative

This supplemental report is being submitted to provide the date received by manufacturer; provide the type of follow-up; provide the type of reportable event; provide the type of follow-up; update the event problem and evaluation codes; and provide additional manufacturer narrative.The device referenced in this report was not returned to siemens for evaluation; however, the system log file was captured and analyzed.During the analysis, it was found two sources that caused the reported issue.The first source is that the ground connection between the common physio module (cpm) and the auxiliary (aux) connector had a small gap that caused the ground not to be properly connected.The second source is that the high frequency noise was coupled to the ground line in the aux cable.These two sources made the cpm more susceptible to electrical noises from sources such as the bovie knife used in the operating room (or).The electrical noise interrupted the communication between the cpm with the rest of the sc2000 system.The root cause of the ultrasound system intermittently losing the echocardiogram (ecg) trace was determined to be the design of the connection of the auxiliary (aux) ecg input of the cpm (cpm recall # z-1200-2018).The reported issue was confirmed based on the results of the ultrasound system log analysis.

• 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: 7307994
• MDR Text Key: 101491916
• Report Number: 3009498591-2018-00009
• 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,user f
• Type of Report: Initial,Followup
• Report Date: 06/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2018
• 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
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/01/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1