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

Model Number	10432915
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Burn(s) (1757); Partial thickness (Second Degree) Burn (2694)
Date of Event	01/03/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to siemens that an adverse event occurred while operating the magnetom skyra system.It was reported that a patient suffered a second degree burn approximately 7 cm in diameter during a pelvic examination.The burn was first treated with debridement followed by medication.No other information was provided by the hospital at the time of this report.Siemens has requested additional information in order to conduct an investigation of the reported event.
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.
Additional Manufacturer Narrative
The investigation of the event and magnetom skyra system has been completed.The root cause has been identified.It was reported to us that a patient suffered a second degree burn in the buttock area during a pelvic examination.The size of the blister is roughly 7 cm in diameter.The burn was treated at first with debridement and then medication.Additional detailed information was not provided by the hospital.Our experts analyzed the logfiles generated during the patient's examination.The complete examination of the patient's pelvis lasted 95.8 min with an active scanning time of 77.8 min.These are high durations.No abnormality was found which would indicate a system malfunction.The complete measurements were performed in the normal operating mode.The sar values were within the limits defined by the mr safety standard (iec 60601-2-33), i.E., the maximum applied sar was 91% of the normal mode limit.The applied rf in this case should not represent a risk under normal circumstances and scan conditions.Furthermore, the patient absorbed 131 wmin/kg which is below the limit of 240 wmin/kg defined in the mr safety standard (iec 60601-2-33).There is no indication of a malfunction of the mr system.The same system and coils have been in use since the occurrence and no other incidents have been reported.In summary no hardware or software problem was found which would explain the reported blister.It was reported to us that the customer closed this incident with the conclusion that the skin burn was caused by the patient's health status and high sed.The patient has diabetics with proven poor thermoregulation ability.This in combination with a comparable long examination time (77 minutes) and a high energy dose applied (131 wmin/kg) caused the 2nd degree burn.

• Brand Name: MAGNETOM SKYRA
• Common Device Name: SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH - MR; henkestrasse 127; erlangen, germany 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 ; 4843234198
• MDR Report Key: 13341936
• Report Number: 3002808157-2022-11404
• Device Sequence Number: 3897709
• Product Code: LNH
• UDI-Device Identifier: 04056869006703
• UDI-Public: 04056869006703
• Combination Product (Y/N): N
• Initial Reporter Country: ID
• PMA/510(K) Number: K163312
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/01/2022

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: 10432915
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/03/2022
• Supplement Date Received by Manufacturer: 06/30/2022
• Initial Report FDA Received Date: 01/25/2022
• Supplement Report FDA Received Date: 07/04/2022
• 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