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

Model Number 7391167

Device Problem Insufficient Information (3190)

Patient Problems Laceration(s) (1946); Joint Dislocation (2374)

Event Date 11/21/2022

Event Type  Injury  

Manufacturer Narrative

Siemens initiated an investigation of the reported incident.A supplemental report will be submitted if additional information is received upon conclusion of the investigation.

Event Description

It was reported to siemens that an oxygen bottle was attracted to the magnet of the magnetom avanto system and injured the operator.The injured person suffered luxation of her thumb saddle joint (right hand) and lacerations.The luxation was treated with a nail and the lacerations required twenty-three (23) to twenty-four (24) sutures.

Manufacturer Narrative

B5: additional information regarding patient treatment was received on 2022/12/05.H10: siemens completed the investigation of the reported event.It was reported that an oxygen bottle was attracted to the system magnet and injured the operator.The injured person needed a surgery because of luxation of the thumb saddle joint (right hand), which was fixed with a nail.Furthermore, the operator suffered cuts on the same hand that needed to be treated with 23 or 24 sutures.Siemens assessed the complained event and concluded that the root 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 generated by the system, special safety measures must be adhered to 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).Additional action by siemens is not warranted.This complaint has been closed.

Event Description

Additional information: the operator underwent surgery to treat the luxation by implantation of a surgical nail.

• Brand Name: MAGNETOM AVANTO
• Type of Device: SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH - MR; henkestrasse 127; erlangen, 91052 ; GM 91052
• Manufacturer (Section G): SIEMENS HEALTHCARE GMBH - MR; henkestrasse 127; erlangen, 91052 ; GM 91052
• Manufacturer Contact: rebecca tudor ; 40 liberty blvd.; 65-1a; malvern, PA 19355 ; 4843234198
• MDR Report Key: 15898214
• MDR Text Key: 304679215
• Report Number: 3002808157-2022-53975
• Device Sequence Number: 1
• Product Code: LNH
• UDI-Device Identifier: 00405689006611
• UDI-Public: 0405689006611
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K181613
• 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: 12/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 7391167
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/21/2022
• Initial Date FDA Received: 12/01/2022
• Supplement Dates Manufacturer Received: 12/05/2022
• Supplement Dates FDA Received: 12/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female