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

Model Number	10432914
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Codes	Patient Problem/Medical Problem (2688); Partial thickness (Second Degree) Burn (2694)
Date of Event	07/27/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Siemens has completed an investigation of the reported event.The root cause was determined to be a user error.The root cause for the 2nd degree burn is a skin to skin contact and therefore a user error.To prevent possible burns, a warning notice is implemented in the magnetom 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 legs.The system is equipped with a squeeze ball and an intercom for the patient to alert the operator in the event of experiencing discomfort.It is the 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.
Event or Problem Description
It was reported to siemens that an adverse event occurred while operating the magnetom aera system.The user reported that a female patient suffered second degree burns on both thighs following examination.The patient presented with redness and blisters approximately 3 cm in diameter.The patient was provided with medical care.No further information regarding the type of treatment was provided.

• Brand Name: MAGNETOM AERA
• Common Device Name: SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH- MR; henkestrasse 127; erlangen, germany 91052 ; GM 91052
• MDR Report Key: 10437310
• Report Number: 3002808157-2020-40244
• Device Sequence Number: 11448906
• Product Code: LNH
• UDI-Device Identifier: 04056869006697
• UDI-Public: 04056869006697
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K190138
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date (Section B): 08/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 10432914
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/29/2020
• Initial Report FDA Received Date: 08/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other