MAUDE Adverse Event Report: SIEMENS HEALTHINEERS ACUSON SEQUOIA; ULTRASOUND DEVICE

Model Number	11148775
Medical Device Problem Codes	Use of Incorrect Control/Treatment Settings (1126); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Fetal Distress (1856)
Date of Event	05/09/2025
Type of Reportable Event	Death
Additional Manufacturer Narrative
Based on preliminary investigation, it is unlikely that the siemens device malfunction may have caused or contributed to the death.Siemens devices follow the aium guidelines for power and provides warnings & guidelines to users via instructions for use on safe usage of the devices during scans.Siemens is performing a detailed investigation of the event and will supplement the report after completion.Reference: (b)(4).
Event or Problem Description
On 12-jun-2025, the designated complaint unit (dcu) received a complaint (b)(4).Per the submitter, on 10-jun-2025, a patient sent a letter to the customer administration (b)(6), strathpine, australia regarding "use of a thermal index for cranial bone (tic) value of 3.03 and 3.16 during two early pregnancy ultrasounds".The letter stated that the patient had undergone two early pregnancy ultrasounds, performed on (b)(6) 2025 and (b)(6) 2025 at the site using the acuson sequoia system with a thermal index for cranial bone (tic) value of 3.03 and 3.16, respectively.Then on (b)(6) 2025, the patient was admitted to the emergency department at (b)(6) hospital due to brown discharge.An ultrasound was performed at the emergency room, and it was found that the baby had no heartbeat, and its growth corresponded to 8 weeks and 3/4 days.The patient further added that 2nd ultrasound on (b)(6) 2025 with (b)(6) had shown a strong heartbeat of 130bpm with 8 weeks 4 days growth which confirms that the baby died in the hours following the ultrasound.The patient states that during both her ultrasound scans at (b)(6) were performed at thermal index for cranial bone (tic) value of 3.03 and 3.16.Per the letter, "according to internationally accepted guidelines, ti and mi values during early pregnancy should be kept below 1.0, preferably under 0.7 - particularly in the first trimester due to the increased sensitivity of developing fetal tissues to thermal effects (source: aium.Org: prudent use and safety of diagnostic ultrasound in pregnancy)." the patient states that there was no advise provided related to the elevated thermal or mechanical output or its potential implications, nor was informed about consent obtained for this level of exposure by the customer at (b)(6).
Additional Manufacturer Narrative
A review of the aium guidelines (source: aium.Org: prudent use and safety of diagnostic ultrasound in pregnancy) for early ob scans (<10 weeks from lmp) was done and the recommendation is to monitor tis (thermal index for soft tissues) values.The asum, isuog guidelines for usage of ultrasound devices for first trimester imaging states "when performing doppler ultrasound, the displayed thermal index (ti) should be less than or equal to 1.0 and exposure time should be kept as short as possible (usually no longer than 5-10 min)." tic (thermal index for cranial bone) values are not relevant for early ob scans, as tic is only for skull (cranial) imaging or similar exams, with wide, thick bone immediately below the skin.In early pregnancy, that thick surface bone is absent in the fetus.Review of the patient images from on (b)(6) 2025 found that the relevant thermal index for this exam is tis.In the first scan (on (b)(6) 2025) tis was below 0.7 and was never above 1.0 for more than one minute.In the second scan (on (b)(6) 2025), tis was always below 0.7.There was no deviation from the standard of care from the asum guidelines.In this case, the customer preset on the system was set to display the tic values during the scans.The system displayed tic value >3 as the thermal index for cranial bone is calculated as if thick surface bone is present.The system calculation is not aware whether such a bone is present or not during this exam.When the users know that such bone is not present, such as early pregnancy cases (<10 weeks), then the users know that value is not applicable.Thus,the output levels used in the scans from the customer using the acuson sequoia system are within the aium/asum guidelines for power.Therefore, it is unlikely that the device malfunction caused or contributed to the death.Reference: (b)(4).

• Brand Name: ACUSON SEQUOIA
• Common Device Name: ULTRASOUND DEVICE
• Manufacturer (Section D): SIEMENS HEALTHINEERS; 22010 south east 51st street; issaquah WA 98029
• Manufacturer (Section G): SIEMENS HEALTHINEERS; 22010 south east 51st street; issaquah WA 98029
• Manufacturer Contact: pragya jai kumar ; 22010 south east 51st street; issaquah, WA 98029
• MDR Report Key: 22216253
• Report Number: 3023245-2025-00051
• Device Sequence Number: 8262083
• Product Code: IYN
• UDI-Device Identifier: 04056869173566
• UDI-Public: (01)04056869173566
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/06/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 11148775
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/16/2025
• Supplement Report FDA Received Date: 08/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Death
• Patient Sex: Unknown