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

Model Number 10018222

Device Problem Insufficient Information (3190)

Patient Problems Erythema (1840); Swelling (2091); Partial thickness (Second Degree) Burn (2694)

Event Date 12/16/2016

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 second degree burn on her right forearm after examination on the magnetom trio system.The patient was positioned head first supine.Towels were wrapped around the arms in order to provide support and keep them level.The patient has a titanium rod and screws placed in the right humerus.Patient has no feeling in right arm.Approximately five hours after the examination, the patient reported redness and a second degree blister, approximately 8 cm in length and 1,5 cm in width on the upper right forearm.The patient was treated by their primary physician with antibiotics and a dressing.

Manufacturer Narrative

The complete examination of the patient brachial plexus lasted 57.9 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 85% 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 50.7 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 cse and found to be operating within specification.The qa of both 3t body matrix mr coils were in specification, however, the coils were removed from the system and sent back to erlangen for investigation.No visual damages were observed and no technical defects were found which would explain the burn on the patient's right forearm.In summary no hardware or software problem was found which would explain the second degree burn on the patient's right forearm.According to the investigation from our experts, the rf burn was likely caused due to the presence of a titanium rod and screws placed in the right humerus.In general, an mr examination is contraindicated for patients with electronic or electronically conductive implants or metals, especially those containing ferromagnetic foreign matter.This is explained in the magnetom trio a tim system operator manual - mr system syngo mr b11, pages 17.

• Brand Name: MAGNETOM TRIO
• Type of Device: SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; allee am roethelheimpark 2; erlangen, 91052 ; GM 91052
• Manufacturer (Section G): SIEMENS HEALTHCARE GMBH, MR QT; henkestrasse 127; erlangen, 91052 ; GM 91052
• Manufacturer Contact: meredith adams ; 40 liberty blvd.; 65-1a; malvern, PA 19355 ; 6104486461
• MDR Report Key: 6295871
• MDR Text Key: 66328554
• Report Number: 2240869-2017-65383
• Device Sequence Number: 1
• Product Code: LNH
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K050200
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date: 01/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 10018222
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/31/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/28/2005
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 21 YR
• Patient Weight: 51