MAUDE Adverse Event Report: SIEMENS MEDICAL SOLUTIONS USA, INC. ACUSON S2000 ULTRASOUND SYSTEM; ULTRASOUND DEVICE

Model Number ACUSON S2000

Device Problems Signal Artifact/Noise (1036); Display or Visual Feedback Problem (1184)

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

Event Date 09/06/2016

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.Reference: (b)(4).Follow-up #1 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), via eco# (b)(4) through plm defect (b)(4).Follow-up #2 narrative: this supplemental report is being submitted to correct the aware date, update the follow up type, indicate the remedial action initiated, and update.For this complaint, the original aware date of the individual case data was 09/06/2016.Not until 03/08/2017, when new data demonstrated the potential for misdiagnosis was this issue determined to be a potential safety issue and an hre was issued.(b)(4) was done for this issue and on 03/13/2017, it resulted in a risk rating of 3b (severity = critical; probability = improbable).This failure mode specifically occurring during breast studies could misrepresent the breast tissue by only displaying a third of the aperture three times.This means two-thirds would not be displayed, causing lesions to be missed or biopsies cancelled.The associated harm may result in serious injury or death (breast cancer) and there are 96 out of 3,179,520 opportunities or 0.030 out of 1000 events (see (b)(4)).Therefore, triple image artifacts for 18l6hd transducer was deemed to be 803 reportable on 03/08/2017 and the complaints related to this issue were reclassified as such.On (b)(6) 2017, it was found that the initial mdr and the supplemental mdr submitted for this complaint on 03/10/2017 and 04/20/2017, respectively, did not document the updated aware date of 03/08/2017, but documented the original aware date of the individual case data.Thus, a new supplemental mdr is being submitted to correct the aware date to 07/03/2017, when the date discrepancy was discovered.The supplement is also providing the results of the investigation.The mixed transducer (fpga), specifically with the 18l6 hd transducer probe, initialization is triggered by transducer power up (sw controlled) and goes through fpga loading from eprom and fpga system register initialization.During this sequence the transducer fpga is sensitive to the pecl clock (sw controlled).In (b)(4) the sw changed the behavior for 18l6 hd and allowed the pecl clock to float for some time.The assumption is that the floating clock signal (system ti board, backplane, transducer fpga) depending on the floating signal level and the transducer fpga input gate sporadically locks up the transducer fpga state machine.From the s family software perspective the technical root cause has been identified as the pecl clock setup and sequence.The issue has now been resolved to align the system software with the transducer so that the power up and sequence is per expectation.This has been further tested over several thousand cycles in order to confirm that the fix is addressing the root cause.The original emdr was submitted to the non-production environment.This report is to submit to the production environment.This emdr contains the initial submission, fu#1 and fu#2.

Event Description

During a retrospective review of the service notifications, it was found that a triple image artifacts were displayed when the 18l6 transducer was used during an unspecified study.The intended study was reported to have been completed with the same transducer.It is believed that the sonographer most likely re-initialized the transducer to clear the fault.There was no patient adverse event reported.No additional information was reported.

• Brand Name: ACUSON S2000 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: 6509180
• MDR Text Key: 287186621
• Report Number: 3009498591-2017-00115
• 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
• Remedial Action: Recall
• 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 S2000
• Device Catalogue Number: 10041461
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/03/2017
• 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