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

Model Number	11061613
Medical Device Problem Codes	Electrical /Electronic Property Problem (1198); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/02/2022
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 3004977335-2022-48000
• Device Sequence Number: 16723234
• Product Code: JAK
• UDI-Device Identifier: 04056869051291
• UDI-Public: 04056869051291
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K200524
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 11061613
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/02/2022
• Supplement Date Received by Manufacturer: 10/27/2022
• Initial Report FDA Received Date: 10/13/2022
• Supplement Report FDA Received Date: 10/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown