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

Model Number 8098027

Device Problems Use of Device Problem (1670); Unintended Electrical Shock (4018)

Patient Problems Electric Shock (2554); Superficial (First Degree) Burn (2685)

Event Date 03/10/2021

Event Type  malfunction  

Manufacturer Narrative

Siemens has initiated a detailed technical investigation of the reported event.A root cause has not yet been identified.A siemens customer service engineer (cse) arrived onsite and found the main breaker in the "off" position and without lights.The cse reset the main power breaker and restarted the somatom definition as system.The a supplemental report will be filed after the completion of the investigation.

Event Description

It was reported to siemens that a technician received an electrical shock to the fifth digit of her hand which resulted in a small blister.The technician sustained the non-critical injury while trying to reset the main circuit breaker in the power distribution cabinet (pdc) after a power outage.The pdc is enclosed by covers and secured with a lock.The technician unlocked the pdc with a key to access the main power breaker switch.She reportedly was having a difficult time trying to switch the power breaker to the "on" position and received the shock to her fifth digit while attempting this.The main breaker was not successfully engaged.The technician declined any medical treatment for the blister.This report is being filed with an abundance of caution.

Manufacturer Narrative

Siemens has completed the technical investigation of the reported event.No device malfunction has been identified.There were no exposed (non-insulated) wires found inside the power cabinet.High voltage warning labels were posted in the appropriate place and the power cabinet was secured with a lock.This event is considered a work accident.The phone support engineer has been re-trained not to allow someone without the appropriate technical training to work inside the cabinet.There was no serious injury and permanent deterioration of health status due to the electrical shock sustained by the facility technician.No further action is warranted.

• Brand Name: SOMATOM DEFINITION AS
• Type of Device: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• MDR Report Key: 11581893
• MDR Text Key: 245122065
• Report Number: 3004977335-2021-71803
• Device Sequence Number: 1
• Product Code: JAK
• UDI-Device Identifier: 04056869003665
• UDI-Public: 04056869003665
• Combination Product (y/n): N
• PMA/PMN Number: K190578
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 04/19/2021

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
• Device Operator: Health Professional
• Device Model Number: 8098027
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 03/10/2021
• Initial Date FDA Received: 03/29/2021
• Supplement Dates Manufacturer Received: 04/19/2021
• Supplement Dates FDA Received: 04/20/2021
• 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
• Patient Age: 52 YR
• Patient Weight: 64