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 Tissue Damage (2104); Injury (2348)

Event Date 03/31/2020

Event Type  Injury  

Manufacturer Narrative

Siemens has completed an investigation of the reported event.The root cause was determined to be the introduction of ferromagnetic pieces into the mr examination room and therefore a user error.Due to the strong magnetic field, particular safety measures have to be adhered to in order to prevent injuries.Therefore, the corresponding magnetom operator manual and the magnetom system owner manual provide clear instructions and warnings regarding both magnetic field hazards and training of personnel with regards to mr safety.The responsibility to instruct personnel and patients who have access to the mr examination room about magnetic field hazards lies with the customer.The manuals state that only equipment specified or recommended for use in the controlled area (mr examination room) shall be used.The introduction of ferromagnetic objects into the magnetic field is contrary to the statements given in the operating instructions.

Event Description

It was reported to siemens that an adverse event occurred while operating the magnetom aera system.It was reported that a ferromagnetic chair was attracted to the magnet resulting in an injury to the operators hand.The injury necessitated surgical intervention including a skin graft.There is no report of impact to the state of health of any patient involved.

Manufacturer Narrative

Siemens has completed an investigation of the reported event.The cause of this event was the introduction of ferromagnetic pieces into the mr examination room and therefore a user error.The operator was transporting the patient to the exam table using a chair.The operator entered the room (back first) looking at the exit door with the patient sitting on the chair.The operator approached the mri table with the chair in a parallel manner until the chair was at 1m - 1m50 from the entrance of the bore.When the chair began to lift towards the bore, the patient was removed from the chair.The operator continued to hold onto the chair as it was drawn to the magnet resulting in the hand injury.There is no report of impact to the state of health of the patient involved.Due to the strong magnetic field, particular safety measures have to be adhered to in order to prevent injuries.Therefore, the corresponding magnetom operator manual and the magnetom system owner manual provide clear instructions and warnings regarding both magnetic field hazards and training of personnel with regards to mr safety.However, the responsibility to instruct personnel and patients who have access to the mr examination room about magnetic field hazards lies with the customer.The manuals state that only equipment specified or recommended for use in the controlled area (mr examination room) shall be used.The introduction of ferromagnetic objects into the magnetic field is contrary to the statements given in the operating instructions.Furthermore special warning signs are posted at the entrance of the controlled access area (magnet room).

• 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
• MDR Report Key: 9936464
• MDR Text Key: 188483805
• Report Number: 3002808157-2020-25977
• 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: company representative,foreig
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date: 03/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2020
• 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: 05/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other