MAUDE Adverse Event Report: SIEMENS MEDICAL SOLUTIONS USA, INC. ACUSON S3000 ULTRASOUND SYSTEM; ULTRASOUND DEVICE

Model Number ACUSON S3000

Device Problem Signal Artifact/Noise (1036)

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

Event Date 02/07/2017

Event Type  malfunction  

Manufacturer Narrative

Original submission narrative: the device referenced in this report has not been returned to siemens for evaluation; therefore, a physical investigation of the device could not be performed.If the device is received at a later date, this report will be supplemented.Follow-up narrative: this supplemental report is being submitted to provide additional manufacturer narrative.Engineering investigated the reported issue and found that the root cause is an initialization issue when the transducer is selected, which occurs roughly 1 in 1000 probe initializations.The interim solution would be to look for the triple image when the transducer is selected, which can be done by pressing a finger on one end of the transducer, and making sure the image is as expected, i.E.You can see one finger on the image.The final solution is to upgrade the software.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

It was reported that during a musculoskeletal procedure, the 18l6 hd transducer displayed a sporadic occurrences of triple image artifact.The procedure was delayed by ten minutes but it was completed with the same device.There was no patient or user injury reported.No additional information was provided.

• Brand Name: ACUSON S3000 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: 6522868
• MDR Text Key: 275004987
• Report Number: 3009498591-2017-00074
• Device Sequence Number: 1
• Product Code: IYN
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K140959
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ACUSON S3000
• Device Catalogue Number: 10441730
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/25/2017
• 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