MAUDE Adverse Event Report: MAGNETOM SKYRA; SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING

Model Number 10432915

Device Problem Excessive Heating (4030)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 12/17/2020

Event Type  Injury  

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 Description

It was reported to siemens that a patient suffered a burn on the left shin (approximately 15 cm x 7 cm in diameter) following examination on the magnetom skyra.It was reported that the patient had undergone a wrist scan for surgery that was completed without incident and the patient was discharged.The patient returned from wrist surgery and reported that their leg was burned during the mr scan.No further information regarding the type of treatment was provided.Siemens has requested additional information in order to conduct an investigation of the reported event.

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.Siemens received an adverse event report from the fda.It was reported that a patient complained about a burn of a size of 15 cm x 7 cm on the anterior aspect of left shin after examination.The patient was undergoing a wrist scan for surgery.The scan was completed without incident and the patient was discharged.The patient returned for wrist surgery and reported that her leg was burned during the first mr scan.According to the information provided, no medical intervention was necessary.Despite several requests for patient images including the rf exposure parameters and further information, they were not provided.Siemens was asked not to contact the customer again to preserve the relationship with siemens and the investigation was stopped.Two months later another complaint was opened for the same incident and dicom images were provided.Our experts analyzed the images generated during the patients' examination.The complete examination of the patient's wrist lasted 50.1 min with an active scanning time of 47 min.No abnormality was found which would indicate a system malfunction.The complete measurement was 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 73 % 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 51.1 wmin/kg which is below the limit of 240 wmin/kg defined in the mr safety standard (iec 60601-2-33).The system was checked by the siemens service engineer and found to be within specification.In summary, no hardware or software problem was found which would explain the reported burn of the patient's left shin.It is not clear where the wrist was placed during examination (i.E.Above head (superman position) or beside the body).In both cases our experts assume that the shin was outside of the magnet.Therefore, we conclude the incident was not related to the mr system.

• Brand Name: MAGNETOM SKYRA
• Type of Device: SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
• MDR Report Key: 11331695
• MDR Text Key: 232053077
• Report Number: 3002808157-2021-65066
• Device Sequence Number: 1
• Product Code: LNH
• Combination Product (y/n): N
• PMA/PMN Number: K121434
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date: 02/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 10432915
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/20/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 71 YR
• Patient Weight: 75