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

Model Number 10684333

Device Problem Use of Device Problem (1670)

Patient Problems Bone Fracture(s) (1870); Head Injury (1879)

Event Date 07/12/2019

Event Type  Injury  

Manufacturer Narrative

Siemens is conducting a thorough investigation of the reported events.As this event is under investigation, a root cause has not yet been determined.A supplement report will be filed upon completion of the investigation.

Event Description

It was reported to siemens that an adverse event occurred while operating the magnetom verio dot system.A magnetic trolley was brought into the examination room and attracted to the magnet resulting in injury to the patient.The patient was immediately moved to a ct scanning room and transferred to the emergency department.It was reported that the patient suffered a rib fracture and injury to the head.Siemens is conducting a thorough investigation of the reported events.As this event is under investigation, a root cause has not yet been determined.A supplement report will be filed upon completion of the investigation.

Manufacturer Narrative

Siemens has completed an investigation of the reported event.The root cause was determined to be a user error.Siemens has 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 corresponding magnetom operator manual 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 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).The manufacturer is not considering further actions resulting from this event as no systematic error has been recognized.

• Brand Name: MAGNETOM VERIO DOT
• Type of Device: SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; henkestrasse 127; erlangen, 91052 ; GM 91052
• MDR Report Key: 8792728
• MDR Text Key: 151106505
• Report Number: 3002808157-2019-89627
• Device Sequence Number: 1
• Product Code: LNH
• Combination Product (y/n): N
• PMA/PMN Number: K121434
• 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: 07/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 10684333
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 50 YR
• Patient Weight: 60