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

Model Number 10432915

Device Problem Use of Device Problem (1670)

Patient Problems Patient Problem/Medical Problem (2688); Partial thickness (Second Degree) Burn (2694)

Event Date 12/11/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).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.(b)(6).

Event Description

It was reported to siemens that an adverse event occurred following use of the magnetom skyra system.The user reported that a patient suffered a second degree burn on the back during a pelvic exam in the area in which a coil was used.The extent of the burn or medical treatment provided is not known at this time.Siemens has requested additional information in order to conduct an investigation.

Manufacturer Narrative

Siemens has completed an investigation of the reported event.Assessment of the log files does not indicate a system failure or malfunction and no non-conformity was identified.System qa has been performed and was found to be generally within specification.Deviations were found (spike check not ok) but are not relevant to a patient burn.Additionally, a coil qa has been performed.A provided photo showed a large blister at the lower back surrounded by a symmetrical, oval redness.The patient was enclosed by two body 30 coils.The burn was approximately in the center of the lower coil.Qa for body 30 (part no: 10835446; serial no.: (b)(4) failed with some stripes on the image.This local coil (according to provided information used on patients back) was provided for investigation.Our experts analyzed the images generated during the patients' examination and other available data.The complete examination of the patient's pelvis and thighs lasted 82 min with an active scanning time of 68 min.No abnormality was found which would indicate a system malfunction.The complete measurement was performed in the first level 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 43% of the first level mode limit.The applied rf in this case should not represent a risk under normal circumstances and scan conditions.Furthermore, the patient absorbed 87.2 wmin/kg which is clearly below the limit of 240 wmin/kg defined in the mr safety standard (iec 60601-2-33).Initial investigation of the local coil showed the body 30 mr 3t coil works as specified.According to our experts some mr-images show strong shading in the lower left of the patient which may indicate a coil problem.Especially a dark stripe might be caused by a strong local b1-enhancement of a factor 2 (180 deg instead of 90 deg), which could fit to coil windings.The local coil was then evaluated for b1 inhomogeneity (dark stripe mentioned above) which could have led to the burn.During the qa, a light oscillation in row 1 could be observed which would result in the faulty qa.This oscillation is also seen in the customer qa.The detuning circuits of the coil are ok and it was concluded that this oscillation is not the reason for the burn/blister.No hardware or software problem was found which would explain the reported burn of the patient.There could be found no evidence with our system being responsible for the complained issue.

• Brand Name: MAGNETOM SKYRA
• Type of Device: SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; henkestrasse 127; erlangen, germany 91052 ; GM 91052
• MDR Report Key: 8482564
• MDR Text Key: 140905449
• Report Number: 3002808157-2019-61179
• Device Sequence Number: 1
• Product Code: LNH
• Combination Product (y/n): N
• PMA/PMN Number: K173592
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date: 12/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2019
• 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
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/13/2018
• Event Location: Hospital
• Date Report to Manufacturer: 12/13/2018
• Date Manufacturer Received: 05/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention