MAUDE Adverse Event Report: SIEMENS HEALTHINEERS ACUSON REDWOOD; ULTRASOUND IMAGING SYSTEM

Model Number 11503314

Device Problem Incorrect Measurement (1383)

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

Event Date 04/27/2023

Event Type  malfunction  

Manufacturer Narrative

The report will be supplemented if after investigation is completed.Reference# (b)(4).

Event Description

The reported issue was submitted as a complaint through pm00372049 for acuson redwood, sn (b)(6) on (b)(6) 2023 from customer dr.Georg pfarl, wien, austria.The customer stated the system was providing different measurements when viewing a thyroid image with the single mode and the dual image mode when using their custom preset.

Manufacturer Narrative

The data from the user was reviewed and testing was performed at the manufacturer.The reported issue was caused by coding error in a specific condition: if the user reuses the preset which was generated for 18l6 for software version va10 in the upgraded sw version va20.This would occur only during dual mode image.Field service correction action update instructions (ui)# us006/23/s was released on 07/13/2023.This update is to distribute the customer safety advisory notification (csan) to all acuson redwood 2.0 (va20) customers to inform of the potential safety concern with user-generated presets of an 18l6 transducer.Also, the improvements to the redwood software will be integrated and released into production in va20h.Reference# (b)(4).

• Brand Name: ACUSON REDWOOD
• Type of Device: ULTRASOUND IMAGING SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHINEERS; 22010 se 51st st; issaquah WA 98029
• Manufacturer Contact: pragya jai kumar ; 22010 se 51st st; issaquah, WA 98029
• MDR Report Key: 16967338
• MDR Text Key: 315940714
• Report Number: 3023245-2023-00015
• Device Sequence Number: 1
• Product Code: IYN
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K210743
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 08/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 11503314
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/05/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization