MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH - MR MAGNETOM SOLA; SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING

Model Number	11291455
Medical Device Problem Code	Excessive Heating (4030)
Health Effect - Clinical Codes	Bruise/Contusion (1754); Pain (1994); Superficial (First Degree) Burn (2685); Blister (4537)
Date of Event	06/08/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a 13-year-old patient felt a burning sensation and pain after several hours following an mr examination of the patient's elbow on (b)(6) 2022.Siemens healthineers conducted a detailed investigation of the incident and based on the then available information and concluded that no there was no indication of serious injury or system malfunction.Therefore, this issue was initially classified as not safety relevant.Subsequently, on (b)(6) 2022, additional information was provided to siemens healthineers about the patient's injury.Siemens healthineers was informed that patient's lateral right thigh and a rectangular shaped area under the right shoulder blade, approximately 2-3 inches from the mid-back, were blistered because of the mri imaging.The patient was treated at home.Professional medical treatment was not sought.
Additional Manufacturer Narrative
A facility contact name was not provided to siemens.Siemens conducted a detailed investigation of the reported event.The system was checked by a service engineer who conducted a detailed examination of the system's records and found that the system performed according to its specifications and defined limits.There was no indication of system malfunction.Additionally, the system's operator manual includes necessary warnings to prevent burns, including direction to a user to avoid patient's direct skin contact with the system and to avoid patient blankets and covers containing metallic threads, requiring use of covers only made of paper, cotton or linen while imaging.Print no.(b)(6).Internal id# (b)(4).

• Brand Name: MAGNETOM SOLA
• Common Device Name: SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH - MR; henkestrasse 127; erlangen, 91052 ; GM 91052
• Manufacturer (Section G): SIEMENS HEALTHCARE GMBH - MR; henkestrasse 127; erlangen, 91052 ; GM 91052
• Manufacturer Contact: rebecca tudor ; 40 liberty blvd.; 65-1a; malvern, PA 19355 ; 4843231498
• MDR Report Key: 15198429
• Report Number: 3002808157-2022-33687
• Device Sequence Number: 6337276
• Product Code: LNH
• UDI-Device Identifier: 04056869164809
• UDI-Public: 04056869164809
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K220425
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/10/2022

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: 11291455
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/22/2022
• Initial Report FDA Received Date: 08/10/2022
• 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
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 13 YR
• Patient Sex: Unknown