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

Model Number 10432915

Device Problem Insufficient Information (3190)

Patient Problems Injury (2348); Partial thickness (Second Degree) Burn (2694)

Event Date 11/27/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).The system was checked by a siemens service engineer and found to be operating within specification.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 an adverse event occurred after examination on the magnetom skyra system.After an mri spine examination, a patient suffered a 2nd degree burn and a superficial area of erythema to the skin on her right lateral pannus (4 cm x 10 cm) and right lateral proximal thigh (2 cm x 10 cm).Medical treatment was administered by a dermatologist.We are unaware of any further impact to the state of health of the patient involved.

Manufacturer Narrative

H10 manufacturer narrative: h3, h6: 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.Siemens has analyzed the images generated during the patients' examination.The complete examination of the patient's t-spine and l-spine lasted 47.4 min with an active scanning time of 40.5 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 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 64.1 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 service engineer and found to be within specification.No hardware or software problem was found which would explain the reported 2nd degree burn of the patient.The root cause for the 2nd degree burn is determined as bore wall contact in conjunction with a relatively long and intensive rf exposure.The patient was adipose (bmi 66 kg/m²).Despite towels as barriers, the patient's hips/legs were in contact with the bore.The direct contact of tissue with the bore wall can result in high-frequency current loops which are capable of causing local burns.To prevent these possible burns a warning notice is implemented in the magnetom family operator manual - mr system syngo mr e11 (page 19-21), which contains the necessary preventive measures.It is requested that direct skin contact must be avoided by using at least a 5 mm thick cushion between the skin and the bore wall.The manufacturer is not considering further actions resulting from this event as no systematic error has been recognized.H11 corrected data: supplemental report number 3002808157-2018-07938 was submitted to the fda on september 28, 2018.Since the manufacturer report number was incorrect and should have been filed as 3002808157-2017-0793, this report is being submitted retrospectively per fda request.

• Brand Name: MAGNETOM SKYRA
• Type of Device: SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; 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 ; 4843234198
• MDR Report Key: 7133176
• MDR Text Key: 95325303
• Report Number: 3002808157-2017-07938
• Device Sequence Number: 1
• Product Code: LNH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141977
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date: 12/04/2017,04/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 10432915
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/04/2017
• Event Location: Hospital
• Date Report to Manufacturer: 12/04/2017
• Date Manufacturer Received: 09/28/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other