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

Model Number 10432914

Device Problem Insufficient Information (3190)

Patient Problems Laceration(s) (1946); Injury (2348)

Event Date 12/15/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Siemens has assessed the complained event and concluded 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.Therefore, the magnetom aera operator manual section 2 and the magnetom system owner manual section 1 provides 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 magnetizable 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).This event occurred in (b)(6).

Event Description

It was reported to siemens that an adverse event occurred while operating the magnetom aera system.It was stated that when bringing a patient into the room, the customer brought in a magnetic drip stick which was attracted to the magnet.While attempting to remove the drip stick, the technician was pinned between the drip stick and the magnet.The technician suffered a laceration to the right index finger requiring 10 sutures.

• Brand Name: MAGNETOM AERA
• Type of Device: SYSTEM, 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 Key: 7137460
• MDR Text Key: 95461293
• Report Number: 3002808157-2017-10156
• Device Sequence Number: 1
• Product Code: LNH
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K132951
• 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: 12/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 10432914
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/15/2017
• Event Location: Hospital
• Date Report to Manufacturer: 12/15/2017
• Date Manufacturer Received: 12/15/2017
• 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): Required Intervention