MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH SOMATOM DEFINITION AS; SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED

Model Number	08098027
Medical Device Problem Code	Unintended Electrical Shock (4018)
Health Effect - Clinical Code	Electric Shock (2554)
Date of Event	12/19/2023
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 while operating the somatom definition as system.It was reported that a radiology technician received an electric shock when trying to reset the f1- breaker in the power distribution cabinet (pdc) of the system.The radiology technician did not suffer any injuries and was medically examined onsite with no negative health findings.Siemens has requested additional information in order to conduct an investigation of the reported event.
Additional Manufacturer Narrative
Siemens healthineers has completed a thorough investigation of the reported event.A siemens field service engineer went onsite and inspected the system.It was found that the toggle of the f1 breaker in the power distribution cabinet (pdc) was broken off.The radiology technician provided information that the toggle broke when he tried to reset it.The breaker was exchanged and sent in for technical investigation at the part supplier.Despite the external damage of the broken toggle, the investigation by the supplier revealed that the power breaker met the technical specifications and left the factory properly and in perfect condition.The investigation furthermore revealed that the gag was damaged by external force, in special by a short increase in force due to shock/impact, so no device malfunction nor general design issue was identified.According to the instructions for use, the components of the system should never be opened by unqualified personnel due to the risk of electrical shock (somatom | syngo ct va48a: c2-029.620.16.03.02 chapter safety, page 31).The radiology technician did not suffer any injuries and was medically examined onsite with no negative health findings.The f1 switch is designed to fulfill all the requirements for electronical safety.Based on the available information and design specification, the electrical shock could not occur on the surface of this switch and this incident is determined to be an isolated case.

• Brand Name: SOMATOM DEFINITION AS
• Common Device Name: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; siemensstrasse 1~or; rittigfeld 1; forchheim 91301 ; GM 91301
• Manufacturer (Section G): SIEMENS HEALTHINEERS AG; siemensstrasse 1 or; rittigfeld 1; forchheim 91301 ; GM 91301
• Manufacturer Contact: meredith adams ; 40 liberty blvd.; malvern, PA 19355 ; 4843231631
• MDR Report Key: 18516424
• Report Number: 3004977335-2024-00002
• Device Sequence Number: 17837558
• Product Code: JAK
• UDI-Device Identifier: 04056869003665
• UDI-Public: 04056869003665
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K230421
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/07/2024

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: 08098027
• Device Catalogue Number: 08098027
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/20/2023
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/16/2024
• Supplement Report FDA Received Date: 10/07/2024
• 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: A
• Patient Sequence Number: 1
• Patient Sex: Unknown