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

Model Number	10655588
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Blister (4537)
Date of Event	03/13/2022
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 following examination on the magnetom spectra mr system.Following a spine scan, the patient complained of blisters.The patient was treated with a cream and no further impact to the patient is known.At this time, no system malfunction has been identified, however, 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.Assessment does not indicate a system failure or malfunction and no non-conformity was identified.It was reported that a patient sustained blisters on her abdomen after spine scanning.The mr system has been checked.No system malfunction was found, and the system works normally.The patient had no tattoos, there was no sar message pop-up during the scanning, and it was confirmed that the squeeze ball is in good condition before and during the examination.The specific energy dose in this case is 3,037.2 j/kg.It is far below the limit of 14,400 j/kg from iec 60601-2-33 "particular requirements for the safety of magnetic resonance equipment for medical diagnosis".The final sed value (3,037.2 j/kg )was a little bit high, which could make patient feel hot.Based on the analysis, sar monitoring worked well during the examination as all system tests passed.The sar value was well below the limit from the safety standard; therefore, this exam fulfilled the safety requirement.The patient wore her clothes with unknown material during the scanning.We cannot confirm whether there is any metal material in her clothes.The safety requirements in operator manual of magnetom spectra (doc id: (b)(6) on page 21) describe the caution of patient wearing and positioning in case of the formation of electric current loop.Based on the above analysis, no system malfunction is detected.In summary no hardware or software problem was found by our system that would explain the patient's burn.

• Brand Name: MAGNETOM SPECTRA
• 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 ; 4843231631
• MDR Report Key: 13900345
• Report Number: 3004754211-2022-20064
• Device Sequence Number: 4303761
• Product Code: LNH
• UDI-Device Identifier: 04056869006796
• UDI-Public: 04056869006796
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K153447
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date (Section B): 03/25/2022

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: 10655588
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/13/2022
• Supplement Date Received by Manufacturer: 05/17/2022
• Initial Report FDA Received Date: 03/25/2022
• Supplement Report FDA Received Date: 05/18/2022
• 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
• Patient Sex: Unknown