MAUDE Adverse Event Report: SOMATOM DRIVE; SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED

Model Number	10431700
Medical Device Problem Code	Unintended Electrical Shock (4018)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The initial reporter is a siemens employee.The reporting facility contact name and phone number were not provided for reporting purposes.Siemens completed a technical investigation of the complaint event.The investigation confirmed that the cabinet was locked, and the high voltage warning labels were in place.The facility electrical cabinet did not have a residual current device installed.The inhouse technician was not certified to work inside the power distribution cabinet (root cause).The inhouse technician who sustained the electrical shock was reminded not to work inside the power distribution cabinet without proper training certification.The investigation confirmed there was no device malfunction, therefore no remedial action is deemed necessary.
Event or Problem Description
It was reported to siemens that the hospital inhouse technician received an electrical shock while working inside the power distribution cabinet (pdc) for the reported ct scanner.The key to the pdc was stored onsite.The technician received the shock when he closed (reset) the f1 fuse by hand.After the incident, the facility monitored his heart rate for an unknown duration of time until it was determined his heart rate was normal.The facility did not report any adverse health consequences as a result of the incident.It was further reported that the technician was not certified to work inside the pdc.The reported event occurred in (b)(6).

• Brand Name: SOMATOM DRIVE
• Common Device Name: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• MDR Report Key: 11919214
• Report Number: 3004977335-2021-80075
• Device Sequence Number: 3202779
• Product Code: JAK
• UDI-Device Identifier: 04056869006970
• UDI-Public: 04056869006970
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: company representative,foreig
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/01/2021

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: 10431700
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/09/2021
• Initial Report FDA Received Date: 06/02/2021
• 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