MAUDE Adverse Event Report: Siemens Medical Solutions USA, Inc. ACUSON S2000; System, Imaging, Pulsed Doppler, Ultrasonic

Catalog Number	10041461
Medical Device Problem Code	Application Program Freezes or Fails to Launch (4031)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2026
Type of Reportable Event	Malfunction

• Brand Name: ACUSON S2000
• Common Device Name: System, Imaging, Pulsed Doppler, Ultrasonic
• Manufacturer (Section D): Siemens Medical Solutions USA, Inc.; 22010 se 51st st; issaquah WA 98029
• Manufacturer (Section G): Siemens Medical Solutions USA, Inc.; 22010 se 51st st; issaquah WA 98029
• Manufacturer Contact: pragya jai kumar ; 22010 se 51st st; issaquah, WA 98029 ; +1(650)625-7209
• MDR Report Key: 50905637
• Report Number: 3023245-2026-00088
• Device Sequence Number: 13452387
• Product Code: IYN
• UDI-Device Identifier: 04056869002774
• UDI-Public: 04056869002774
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Type of Report: Initial
• Report Date (Section B): 09/25/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 10041461
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/01/2026
• Initial Report FDA Received Date: 09/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown