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

Model Number 10432914

Device Problem Use of Device Problem (1670)

Patient Problems Patient Problem/Medical Problem (2688); Partial thickness (Second Degree) Burn (2694)

Event Date 07/27/2020

Event Type  Injury  

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 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
• Type of Device: SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH- MR; henkestrasse 127; erlangen, germany 91052 ; GM 91052
• Manufacturer (Section G): SIEMENS HEALTHCARE GMBH- MR; henkestrasse 127; erlangen, germany 91052 ; GM 91052
• Manufacturer Contact: meredith adams ; 40 liberty blvd.; 65-1a; malvern, pa ; 4486461
• MDR Report Key: 10437310
• MDR Text Key: 204032940
• Report Number: 3002808157-2020-40244
• Device Sequence Number: 1
• Product Code: LNH
• UDI-Device Identifier: 04056869006697
• UDI-Public: 04056869006697
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K190138
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 08/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

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