MAUDE Adverse Event Report: SIEMENS MEDICAL SOLUTIONS USA, INC.; SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC

Catalog Number	11148775
Medical Device Problem Code	Loss of Data (2903)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/26/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Copied from (b)(4).No images found in study after closing it locally.System would have stored a study queried from mwl server as "unbekannt" (unknown).
Additional Manufacturer Narrative
Drew rus attention to skb0105207, known issue: patient's name changed to unknown upon registration from worklist.And explained this furthermore possible workarounds: have customer to be aware to check if started study still has a proper patient name etc.In it's data field and to eventually start again with a new query, if not.- disable autoquery check patient browser with customer searching for patient id starting with "23" or patient name "unbekannt" to show, that no exam data has gone lost.Studies should be on the pacs as well, as system is set to store onstudyclose.

• 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 ; 6506257209
• MDR Report Key: 21750833
• Report Number: 3009498591-2025-00008
• Device Sequence Number: 12817217
• Product Code: IYN
• UDI-Device Identifier: 04056869173566
• UDI-Public: 04056869173566
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/31/2025

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
• Device Catalogue Number: 11148775
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/26/2023
• Initial Report FDA Received Date: 04/02/2025
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown