MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH MAGNETOM SYMPHONY A TIM SYSTEM; MAGNETIC RESONANCE DIAGNOSTIC DEVICE

Model Number	10018223
Health Effect - Clinical Codes	Burn(s) (1757); Numbness (2415); Cryogenic Burn (4539)
Date of Event	03/06/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
Siemens became aware of an incident that occurred on the magnetom symphony unit.Siemens customer service engineer (cse) mounted the current lead into the magnet and checked the mag voltage to ramp down the system.The mag voltage was out of tolerance, therefore, the engineer tried to take out the current lead; during this activity a sudden system quench started.When quench occurred, the engineer tried to close the current lead port but lost consciousness (possibly due to low oxygen levels caused by high helium leak).The engineer fell down the magnet ladder to the floor and suffered a cold burn to the right hand as well as numbness and loss of sensation in his left leg.The cold burn was treated with antibiotic burn cream.A neurologist and orthopedist examined the left leg and performed an mri scan of the lumber.The engineer had to receive physical therapy following the incident.However, the treatment did not have the expected effect.The engineer continues to experience numbness and loss of sensation in the left leg.Therefore, it was decided to perform a surgery after the covid pandemic.The incident has already been investigated.The incident occurred due to a working error as the engineer did not wear the correct ppe (personal protection equipment).The reported incident occurred in (b)(6).

• Brand Name: MAGNETOM SYMPHONY A TIM SYSTEM
• Common Device Name: MAGNETIC RESONANCE DIAGNOSTIC DEVICE
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; henkesstrasse 127; erlangen, 91052 ; GM 91052
• MDR Report Key: 11019847
• Report Number: 3002808157-2020-24512
• Device Sequence Number: 16331873
• Product Code: LNH
• UDI-Device Identifier: 04056869020471
• UDI-Public: 04056869020471
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K050199
• 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): 12/16/2020

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: 10018223
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/16/2020
• Initial Report FDA Received Date: 12/16/2020
• 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