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

Model Number 10432915

Device Problem Use of Device Problem (1670)

Patient Problems Burn(s) (1757); Injury (2348); Full thickness (Third Degree) Burn (2696)

Event Date 04/21/2020

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 an adverse event occurred following examination on the magnetom skyra system.A sedated patient suffered a 3rd degree burn to the lateral left elbow approximately 10 cm x 6 cm in diameter during a shoulder scan.The patient was positioned with arms at the side and slightly raised from the table with a towel to facilitate better positioning of iv tubing.Additionally, longitudinal pads were used for positioning as well as a pillow case on the left side, a knee cushion, and a strap and sandbag to hold the body 18 coil across the upper chest area.The injury was observed immediately after examination by the technologist and physician.At this time, treatment is ongoing.Siemens has requested additional information in order to conduct an investigation of the reported event.

Manufacturer Narrative

Siemens completed an investigation of the reported incident.Our experts analyzed the images generated during the patient examination.The complete examination of the patient's right shoulder continued for 82.2 min with an active scanning time of 58.2 min (note: these are long durations).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 100% of the normal mode limit.The applied rf in this case does not represent risk under normal circumstances and scan conditions, although maximum limit was applied.Furthermore, the patient absorbed 112.5 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 siemens local service and found to be within specifications.In summary no hardware or software issues were identified to explain the burn on the patient's elbow.It was stated that longitudinal pads were used for positioning as well as a pillowcase on the left side, to avoid direct skin contact to the bore wall.Nevertheless, our experts assume due to the location of the burn on the lateral left elbow and patient positioning in the bore, the elbow came in direct or close contact to the bore wall.Most probably the spacer cushion used was strongly compressed in the area of the elbow, or possibly slipped away when the patient (with a bmi of 34.2 kg/m²) was moved into the magnet.Furthermore, the patient was anesthetized, and a very intense examination has been carried out - in terms of duration, intensity and the applied sed value as well.It is assumed that the root cause for the 3rd degree burn was a combination of a contact with a bore, as well as long duration of the examination with intensive rf exposure.To prevent possible burns a warning notice is implemented in the magenetom family - operator manual - mr-system - syngo mr e11 (p.19-21), which contains the necessary preventive measures.It is requested that direct skin contact must be avoided by using an at least 5 mm thick cushion between the skin and the bore wall.Due to the patient being under anesthesia, the operator had no feedback on endangering temperature rise in the tissue.In chapter 5 (page 19) of the operator manual is a safety instruction on rf and gradient fields: do not examine patients unable to communicate potential overheating effects (e.G.Small children, seriously ill, paralyzed, unconscious, sedated, or handicapped patients).It is user's responsibility to follow the instructions given in the operator manual, regarding correct patient positioning and monitoring in order to avoid such incidents in the future.

• Brand Name: MAGNETOM SKYRA
• Type of Device: SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH- MR; henkestrasse 127; erlangen, germany 91052 ; GM 91052
• MDR Report Key: 10070735
• MDR Text Key: 191431176
• Report Number: 3002808157-2020-27964
• Device Sequence Number: 1
• Product Code: LNH
• Combination Product (y/n): N
• PMA/PMN Number: K163312
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 05/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2020
• 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: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 56 YR
• Patient Weight: 104