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

Model Number 11061613

Device Problems Electrical /Electronic Property Problem (1198); No Apparent Adverse Event (3189)

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

Event Date 10/02/2022

Event Type  malfunction  

Manufacturer Narrative

Siemens is conducting a thorough investigation of the reported events.As this event is under investigation, a root cause has not yet been determined.A supplement report will be filed upon completion of the investigation.

Event Description

It was reported to siemens that a malfunction occurred with the somatom go.Now ct system.A service engineer visited the customer to check the condition of the site and was notified that a fire had occurred in the gantry room on (b)(6), 2022.According to available information, the root cause was a short circuit on the customer´s power cables.The customer reported that the fire was extinguished by the fire department.As a result of the fire, the gantry covers were melted.There is no report of impact to the state of health of any patient or user involved.At this time, there is no indication that the ct device may have contributed to this event.Siemens has requested additional information in order to conduct an investigation of the reported event.

Manufacturer Narrative

Siemens completed the technical investigation of the reported event according to the information received, the siemens ct system neither caused nor contributed to the fire accident.The root cause of the problem was an internal short circuit near the customer's control panel and the air conditioning (ac) system.The short-circuit cable was not part of the siemens system and was the customer's responsibility.Also, the siemens ct system was switched off at the time when the fire accident occurred.No general design issue was identified.No further investigation within the complaint process is necessary.The complaint will be closed.

• Brand Name: SOMATOM GO.NOW
• 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; siemensstr. 1 or rittigfeld 1; rittigfeld 1; forchheim, 91301 ; GM 91301
• Manufacturer Contact: rebecca tudor ; 40 liberty blvd.; 65-1a; malvern, PA 19355 ; 4843234198
• MDR Report Key: 15594326
• MDR Text Key: 301773876
• Report Number: 3004977335-2022-48000
• Device Sequence Number: 1
• Product Code: JAK
• UDI-Device Identifier: 04056869051291
• UDI-Public: 04056869051291
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K200524
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 11061613
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/27/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1