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

Model Number 11291455

Device Problem Use of Device Problem (1670)

Patient Problems Burn(s) (1757); Injury (2348); Partial thickness (Second Degree) Burn (2694)

Event Date 05/01/2019

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 an adverse event occurred following examination on the magnetom sola system.A (b)(6) year old male patient with metal hip implants suffered several small blisters and an area of redness bilaterally above the knees on the inner thighs approximately twenty minutes after examination.After several sequences, the patient alerted the operator that he felt heating in the scanning area of the hips.The examination was continued and completed.The patient applied a topical burn cream as treatment as no major medical intervention was necessary.However, the patient is reporting that the wound is still active, experiencing deep burns and continued erythematous to the affected area.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 of the log files does not indicate a system failure or malfunction and no non-conformity was identified.During investigation siemens became aware that a second degree burn was associated with this issue (several small blisters and redness, two marks each side symmetrical on inner lower thigh).The issue was reported to authorities due to healing complications.Approximately twenty minutes after the hip examination the patient detected blisters on both inner thighs.Though cushions were used between the ankles, the mr images show that no cushion was placed between the thighs.Two local coils were provided for investigation: the spine 32 mr coil 1.5t (part number: 11134378, serial number: (b)(6)) was checked.There were some minor deviations, but these deviations were not the root cause for the warming.The body 18 mr coil 1.5t (part number: 10496530, serial number: (b)(6)) was checked.The coil works as specified.Our experts analyzed the images generated during the patients' examination.The complete examination of the patient's hip area lasted 34.1 min with an active scanning time of 25.3 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 57% 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 60.8 wmin/kg which is clearly below the limit of 240 wmin/kg defined in the mr safety standard (iec 60601-2-33).The magnetom vida, magnetom sola operator manual - mr system syngo mr xa11 (p.34) gives information regarding the usage of the first level mode, e.G.: all patients should receive at least routine monitoring.For some (e.G.Sedated, physically unstable) patients, monitoring of the vital parameters is mandatory.In the first level controlled operating mode medical supervision is also mandatory.Medical supervision means adequate medical management of patients who can be at risk from some parameters of exposure to the mr equipment, either because of the medical condition of the patient, the levels of exposure or a combination.In summary no hardware or software problem was found which would explain the reported burns of the patient.Furthermore, it was stated that the patient had bilateral hip implants.The root cause for the burns is considered to be an rf current loop (skin-to-skin-contact between the thighs).This effect is described in the magnetom vida, magnetom sola operator manual - mr system syngo mr xa11 (p.21ff).Please always follow the instructions given in the operator manual, regarding correct patient positioning in order to avoid such incidents in the future.- always position the patient so that the patient's arms are aligned with the torso and ensure that hands, arms, and legs do not touch (minimum distance: 5 mm).- ensure that the minimum distance of 5 mm is maintained between patient and tunnel covering.- to ensure this distance, use positioning aids, e.G.Blankets made of linen, cotton, or paper, or dry material that is permeable to air.Additionally, the magnetom vida, magnetom sola operator manual - mr system syngo mr xa11 (p.24ff) gives information and warnings regarding contraindications for mr when scanning patients with implants.The manufacturer is not considering further actions resulting from this event as no systematic error has been recognized.

• Brand Name: MAGNETOM SOLA
• Type of Device: SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; henkestrasse 127; erlangen, germany 91052 ; GM 91052
• MDR Report Key: 8726379
• MDR Text Key: 148921871
• Report Number: 3002808157-2019-80178
• Device Sequence Number: 1
• Product Code: LNH
• Combination Product (y/n): N
• PMA/PMN Number: K182129
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date: 06/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 11291455
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 66 YR
• Patient Weight: 79