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

Model Number 11061640

Device Problems Circuit Failure (1089); Intermittent Continuity (1121)

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

Event Date 07/27/2023

Event Type  malfunction  

Event Description

It was reported to siemens that a malfunction occurred while operating the somatom go.Top ct system.On (b)(6), 2023, an emergency stroke patient was planned for a ct scan, however, the scan was interrupted with an error message.The customer contacted siemens for support, and it was detected that the connection to the control box was lost.After the connection was reseated, completion of the scan was possible.As a result of the error message, the scan was delayed for approximately two minutes.No negative health consequence was reported for the patient involved.

Manufacturer Narrative

Siemens has completed an evaluation of the event.The event caused a minor delay in treatment; therefore, this report is filed with an abundance of caution.A siemens service engineer went onsite to check the cable connections.The cable was exchanged, and the system was returned to regular operation.The exchanged cable has been requested for investigation.If the investigation results in a systematic or design issue, a supplemental report will be filed.

• Brand Name: SOMATOM GO.TOP
• Type of Device: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; siemensstrasse 1~or; rittigfeld 1; forchheim 91301 ; GM 91301
• Manufacturer (Section G): SIEMENS HEALTHCARE GMBH; siemensstrasse 1 ~or; rittigfeld 1; forchheim 91301 ; GM 91301
• Manufacturer Contact: meredith adams ; 40 liberty blvd.; malvern, PA 19355 ; 4843231631
• MDR Report Key: 17571897
• MDR Text Key: 321423361
• Report Number: 3004977335-2023-00091
• 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
• Type of Report: Initial
• Report Date: 08/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 11061640
• Device Catalogue Number: 11061640
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1