MAUDE Adverse Event Report: SIEMENS MEDICAL SOLUTIONS USA, INC. ACUSON S1000 ULTRASOUND SYSTEM; ULTRASOUND DEVICE

Model Number ACUSON S1000

Device Problems Signal Artifact/Noise (1036); Output Problem (3005)

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

Event Date 02/23/2017

Event Type  malfunction  

Manufacturer Narrative

Original submission 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 at a later date, this report will be supplemented.(b)(4).Follow-up narrative: this supplemental report is being submitted to update the event problem and evaluation codes and to provide additional manufacturer narrative.The device was not returned but the savelogs were reviewed and it was found that the root cause of the triple images 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.This issue was resolved in (b)(4).Note: the original emdr was submitted to the non-production environment.This report is to submit to the production environment.This emdr contains both the initial and fu#1.

Event Description

It was reported that in the middle of a breast study, the 18l6 hd transducer generated a triple image artifacts which were displayed on the ultrasound system.The study was continued and completed on the same system but the transducer was replaced with the 9l4.There was no loss of data and there was no patient adverse event reported.No additional information was provided.

• Brand Name: ACUSON S1000 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: 6509112
• MDR Text Key: 282721226
• Report Number: 3009498591-2017-00113
• Device Sequence Number: 1
• Product Code: IYN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140959
• 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,Followup
• Report Date: 10/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ACUSON S1000
• Device Catalogue Number: 10441701
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/19/2017
• 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