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

Model Number 10018165

Device Problem Use of Device Problem (1670)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 06/08/2023

Event Type  Injury  

Manufacturer Narrative

E1: a facility contact name was not provided for reporting.The facility telephone number is (b)(6).H3, h6: the investigation is ongoing.A supplemental report will be submitted if additional information is obtained upon the completion of the investigation.

Event Description

An adverse event involving the magnetom espree system was reported to siemens by the customer.The mr technologist entered the mri examination room after retrieving an old host computer from the adjacent technical room.When the technologist walked through the mri examination room with the computer, the computer was attracted by the magnetic field of the mri and was subsequently torn from her hands, resulting in one of her fingers (fifth digit) being amputated as the computer was pulled into the magnet.The technologist was sent to a surgeon at the customer facility but unfortunately, the technologist¿s finger could not be reattached.

Manufacturer Narrative

The reported event was analyzed, and it was concluded that the cause of this event was the introduction of ferromagnetic pieces into the mr examination room and, therefore, an individual user error.Due to the strong magnetic field, special safety measures must 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, the required warning signs were present on both sides of the entrance door of the controlled access area (magnet room).

• Brand Name: MAGNETOM ESPREE
• 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: anastasia sokolova ; 40 liberty blvd.,; mc 65-1a; malvern, PA 19464 ; 4843234197
• MDR Report Key: 17190136
• MDR Text Key: 317733829
• Report Number: 3002808157-2023-00003
• Device Sequence Number: 1
• Product Code: LNH
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K041112
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 10018165
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Disability