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

Model Number ACUSON SC2000

Device Problem Leak/Splash (1354)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/24/2015

Event Type  malfunction  

Manufacturer Narrative

Original submission narrative: the device referenced in this report was returned to siemens for evaluation.The system error was unable to be reproduced.During visual inspection, it was found that the articulation sleeve was torn by friction with the disinfection tube.The likely cause of the reported phenomenon is that liquid had infiltrated into articulation sleeve and affected the electrical parts which led to system error.A review of the device history record (dhr) was performed and there is no information to indicate any non-conformance at the time of manufacturing process.Follow-up narrative: this supplemental report is being submitted to update the device available for evaluation, update the follow-up type , update the device evaluated by manufacturer , update the event problem and evaluation codes, and provide the investigation results.Investigation: during the device investigation, the system error was not reproduced.However, a tear in the articulation sleeve was found which appears to have been caused by an external force.Liquid can infiltrate into articulation sleeve, and affect the electrical components.It was recommended that the customer not use the disinfection tube.Note: the original emdr was submitted to the non-production environment.This report is to submit to the production environment.All original files are attached.This emdr contains both the initial and fu#1.

Event Description

As a result of a recent fda inspection, we are retrospectively reviewing complaints and associated documents for compliance to the regulations from 2015 to date.We have strengthened our mdr reporting criteria and we are reporting the attached medical device report in accordance with our new criteria.As a result of this retrospective review, this mdr is being reported immediately upon discovery.It was reported that during leakage current test, it was observed that there are nicks on the transducer cable near the articulating scanhead.There was no procedure being performed so there was no patient involvement.No additional information was provided.

• Brand Name: ACUSON SC2000 ULTRASOUND SYSTEM
• Type of Device: ULTRASOUND DEVICE
• Manufacturer (Section D): SIEMENS MEDICAL SOLUTIONS USA, INC.; business area ultrasound; 22010 se 51st street; issaquah WA 98029
• Manufacturer Contact: khalil thomas ; business area ultrasound; 22010 se 51st street; issaquah, WA 98029 ; 4253929180
• MDR Report Key: 6316114
• MDR Text Key: 271005488
• Report Number: 3009498591-2016-00396
• Device Sequence Number: 1
• Product Code: IYO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142628
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2017
• 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: 10436113
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2015
• Date Manufacturer Received: 09/24/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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