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U.S. Department of Health and Human Services

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

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SIEMENS HEALTHCARE GMBH MAGNETOM AERA SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING Back to Search Results
Model Number 10432914
Device Problem Use of Device Problem (1670)
Patient Problems Brain Injury (2219); Patient Problem/Medical Problem (2688)
Event Date 10/01/2019
Event Type  Injury  
Manufacturer Narrative
The investigation concludes that the cause of this event was 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. 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. Furthermore, special warning signs are posted at the entrance of the controlled access area (magnet room). No further actions are to be taken as there is no negative awareness in regards to the quality and performance of the mr system.
 
Event Description
It was reported to siemens that an adverse event occurred while operating the magnetom aera system. The user reported that a ferromagnetic sand bag was attracted to the magnet while positioning a patient. The sand bag was located inside the patients diaper and was not seen by the technician during the patients preparation. The ferrous sand bag was pulled into the magnet hitting the patients jaw and lifting the head coils anterior section. It was reported that the patient survived but may have suffered a brain injury.
 
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Brand NameMAGNETOM AERA
Type of DeviceSYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
Manufacturer (Section D)
SIEMENS HEALTHCARE GMBH
henkestrasse 127
erlangen, 91052
GM 91052
Manufacturer (Section G)
SIEMENS HEALTHCARE GMBH
henkestrasse 127
erlangen, 91052
GM 91052
Manufacturer Contact
meredith adams
40 liberty blvd.
65-1a
malvern, PA 19355
6104486461
MDR Report Key9192217
MDR Text Key162691648
Report Number3002808157-2019-01184
Device Sequence Number1
Product Code LNH
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K141977
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation
Remedial Action Inspection
Type of Report Initial
Report Date 10/01/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/15/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number10432914
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/01/2019
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

Patient Treatment Data
Date Received: 10/15/2019 Patient Sequence Number: 1
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