MAUDE Adverse Event Report: SIEMENS SHENZHEN MAGNETIC RESONANCE LTD. MAGNETOM ESSENZA DOT; SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING

Model Number	10836618
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Codes	Tinnitus (2103); Superficial (First Degree) Burn (2685)
Date of Event	08/19/2021
Type of Reportable Event	Serious Injury
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 an adverse event occurred while performing maintenance on the magnetom essenza dot system.A siemens service engineer was injured when an electrical connector on a power cable (mref power cable) sparkled when turning on the circuit breaker inside the cooling cabinet during maintenance.The siemens service engineer suffered a first degree burn to the right hand.The skin on the right hand was sensitive to the touch at that time but did not require any treatment.Additionally, it was reported that the siemens service engineer was wearing a hearing aid at the time of the event and suffered hearing loss.It is not known if the hearing loss is permanent as the siemens service engineer reports to still be experiencing tinnitus but has not yet visited a doctor.Siemens has requested additional information in order to conduct an investigation of the reported event.
Additional Manufacturer Narrative
Siemens has completed an investigation of the reported event.The root cause was determined to be a workmanship error.Based on the information provided by the service engineer, the circuit breaker for the cooling cabinet tripped on site.After trouble shooting, the cse didn't find any abnormalities and turned the breaker on directly without powering off the main first.According to the required technical documentation, the correct operation is as follows: power off the main line in main box first; turn on the circuit breaker in e-box and close the cover of the e-box; power on the main line in main-box.Additionally, the label with electrical warning information on the cover panel of the e-box is marked with "disconnect power before servicing unit." therefore, the reported incident was the result of a workmanship error.

• Brand Name: MAGNETOM ESSENZA DOT
• Common Device Name: SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
• Manufacturer (Section D): SIEMENS SHENZHEN MAGNETIC RESONANCE LTD.; gaoxin c ave.; 2nd, hi-tech industrial park; shenzhen, china 51805 7; CH 518057
• Manufacturer (Section G): SIEMENS SHENZHEN MAGNETIC RESONANCE LTD.; gaoxin c ave.; 2nd, hi-tech industrial park; shenzhen, china 51805 7; CH 518057
• Manufacturer Contact: meredith adams ; 40 liberty blvd.; malvern, PA 19355 ; 6104486461
• MDR Report Key: 12452318
• Report Number: 3004754211-2021-94676
• Device Sequence Number: 11057684
• Product Code: LNH
• UDI-Device Identifier: 04056869006789
• UDI-Public: 04056869006789
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K161795
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date (Section B): 09/10/2021

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: 10836618
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/19/2021
• Supplement Date Received by Manufacturer: 01/17/2022
• Initial Report FDA Received Date: 09/10/2021
• Supplement Report FDA Received Date: 01/17/2022
• 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