MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH-CT SOMATOM GO.TOP; SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED

Model Number 11061640

Device Problems Computer Software Problem (1112); Loss of Data (2903)

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

Event Date 11/20/2022

Event Type  malfunction  

Manufacturer Narrative

Siemens has completed an investigation of the event.Assessment of the log files does not indicate a system failure or malfunction and no non-conformity was identified.Investigation revealed that the system worked as specified.The customer had deleted the raw data before continuing the reconstruction.Based on the available information no general design issue was identified.

Event Description

It was reported to siemens that a malfunction occurred while operating the somatom go.Top ct system.The customer reported that the images of a cta head stroke protocol study performed on (b)(6) 2022, could not be reconstructed on (b)(6) 2022.The patient was scanned with two spirals.Both raw data files did not later exist in the image reconstruction system (irs).The patient is a pregnant female (approx.Week 32 at time of scan) and was not rescanned.No negative health consequences were reported.We consider pregnant patients as a special population group who needs to be protected.Therefore, this report is filed with an abundance of caution.

• Brand Name: SOMATOM GO.TOP
• Type of Device: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH-CT; siemensstr. 1 -or-; rittigfeld 1; forchheim, germany 91301 ; GM 91301
• Manufacturer (Section G): SIEMENS HEALTHCARE GMBH-CT; siemensstr. 1 -or-; rittigfeld 1; forchheim, germany 91301 ; GM 91301
• Manufacturer Contact: meredith adams ; 40 liberty blvd.; malvern, PA 19355 ; 4843231631
• MDR Report Key: 15996203
• MDR Text Key: 305809230
• Report Number: 3004977335-2022-54213
• Device Sequence Number: 1
• Product Code: JAK
• UDI-Device Identifier: 04056869151571
• UDI-Public: 04056869151571
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K211373
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 12/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 11061640
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 11/25/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Sex: Female