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

Model Number	8098027
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Electric Shock (2554)
Date of Event	10/27/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Siemens has completed an investigation of the reported event.The root cause was determined to be a user error.Regardless that unqualified personnel attempted to reset the breaker; we do not see any correlation between using the broken knob as a key in the breaker and the electric shock, as the breaker and the knob itself do not have any exposed contactors.It is more likely that the technologist came in contact with another part within the power cabinet, however, it was not possible to clarify this in more detail.According to the instructions for use, the customer/technician should never open any components of the system and leave all repairs to the siemens service.(print no.C2-029.620.16.03.02, page 31, risk of electrical shock).Access to the power cabinet is restricted to authorized service personnel by locks.The door of the cabinet has a key lock.No further actions are to be taken as there is no negative awareness regarding the quality and performance of the ct system.
Event or Problem Description
It was reported to siemens that an adverse event occurred while operating the somatom definition as ct system.On (b)(6), 2022, a technologist received an electrical shock while resetting a breaker.The customer facility was conducting prolonged testing on their generator.Each time the power switch-over occurred, it tripped the f1 breaker in the power distribution cabinet (pdc) of the ct scanner.The customer contacted siemens for advice in a situation such as this and was advised to place a service call or to have an electrician or clinical engineering personnel turn the breaker back on.As the facility did not want to wait for a siemens engineer to come onsite nor to have qualified personal reset the breaker, the unqualified technologist would reset the breaker when necessary.While doing so, a technologist broke the breaker knob on the f1 breaker.The facility did not place a service call for repair.The generator testing caused the breaker to trip again and a technologist attempted to use the broken knob as a key to turn the breaker and received an electrical shock by the knob.It was confirmed that the technologist did not suffer any serious injury and no medical intervention was required.

• Brand Name: SOMATOM DEFINITION AS
• 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-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: 15851374
• Report Number: 3004977335-2022-51401
• Device Sequence Number: 5216455
• Product Code: JAK
• UDI-Device Identifier: 04056869003665
• UDI-Public: 04056869003665
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K190578
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date (Section B): 11/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 8098027
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/28/2022
• Initial Report FDA Received Date: 11/23/2022
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown