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

Model Number	10849579
Medical Device Problem Code	Fire (1245)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/23/2022
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2022, it was reported that during a patient examination using the magnetom avanto fit system, a loud bang was heard from the rear of the system and a small amount of smoke was seen.The vlm unit detected a hardware malfunction, and the technician removed the patient.Approximately one hour later, a fire started in the magnet room at the backside of the system magnet.The system was switched off by the vlm.The local fire department was called, and the firefighters quenched the system using the erdu button and switched off the power (epo).The firefighters extinguished the fire in the room and system.The customer service engineer found a broken y-gradient cable on the gradient connection plate at the backside of the magnet.There was no reported injury due to this event.On july 8, 2022, a siemens expert visited the site and informed siemens about the extent of the fire.All components of the system located in the magnet room are damaged by the fire, the smoke, and the extinguishing water.The reported event occurred in the netherlands.
Additional Manufacturer Narrative
Initial reporter: a facility contact name was not provided to siemens.A siemens employee provided the information for this report.A post quench was performed on (b)(6) 2022.It was observed that the auxiliary burst disc ruptured; a black plate was placed.The graphite burst disc looks intact.The system is now building up pressure.The cooling system will not run again due to burn/damage.Siemens has initiated a technical evaluation of the reported event.A supplemental report will be submitted if additional information is obtained or upon completion of the investigation.Internal id# (b)(4).
Additional Manufacturer Narrative
The investigation of the reported event is still ongoing as of the date of this report.A supplemental report will be filed upon completion of the investigation.Internal id# (b)(4).
Additional Manufacturer Narrative
As previously reported siemens was informed about a fire on a magnetom avanto fit system (material number: (b)(6), serial number: (b)(6).When the vlm unit (smoke detector) detected the smoke, the hospital staff was informed to evacuate the patient immediately and the system was shut down.Nevertheless, a fire had ignited.Per the complaint report there was no injury associated with this issue.It was stated in the complaint description that on (b)(6) 2022 a "loud bang" occurred and the vlm unit detected a hardware malfunction.The patient was evacuated safely.At first, smoke was detected from the backside of the mri; then the system caught on fire.The firefighters were alarmed, who quenched the system, switched off the power (epo) and extinguished the fire.We were informed by our hsc that the local cse found the y-gradient cable broken on the gradient connection plate at the backside of the magnet.On (b)(6) 2022 our hsc expert visited the affected site.During this visit, the vlm connections were checked, vlm logs were downloaded, the latest data from the host was saved and the system operator was interviewed.Furthermore, we were informed about the extent of the fire.Finally, the gradient connection plate was dismounted and taken back to erlangen for further investigation.Root cause: siemens experts thoroughly investigated this issue at our manufacturing site based on this information.According to the savelog and the log file of the vlm, there were two events in the afternoon of the same day (around 3:44 pm and 03:53 pm) that show an increased smoke concentration at the internal smoke detector.These events however did not reach the smoke alarm threshold of the vlm to trigger a switch off.The defined threshold is a measured smoke concentration greater than 0.2 % for more than 10 seconds.This threshold is chosen with great care: a lower threshold can lead to the fact that already the normal air is recognized as smoke.The third event (around 04:31 pm) however reached the defined threshold.Consequently, the gradient power amplifier was switched off and the system warned the operator to evacuate the patient from the system.After the evacuation of the patient, smoke was seen in the magnet room and a fire ignited, which needed to be extinguished manually.The gradient connection plate was investigated in erlangen together with the insurance responsible.Our experts determined that the root cause of the smoke and fire is a broken cable lug at the rear connection plate of the gradient cables.Based on this complaint an internal risk assessment was performed to evaluate the risk on such an incident and to deduce whether mitigating measures need to be initiated.Mri technology requires strong gradient fields for a high image quality.The required gradient fields can be generated by high electrical power.As required per product risk analysis there are safety mechanisms implemented (e.G., the vlm), but there is still a residual risk of smoke or excessive heating.Therefore, all severities were considered on this topic.With regards to the probability, it was decided to make a complaint evaluation considering all complaints of the last five years with broken cable lugs at the gradient cables for the systems magnetom avanto (incl.Dot systems) and magnetom avanto fit since the vlm suction nozzle is positioned similarly in these systems.In total, 11 complaints were identified matching these criteria.Among these complaints the case described is the only one that has resulted in a fire.Furthermore, in none of these cases was an injury reported.Based on the complaint assessment and the estimated probability of occurrence of harm as well as the considered severity of harm, the resulting residual risks can be classified within an acceptable risk area.Therefore, from product risk management point of view no measure is required for the above listed systems.The analysis of the connection plate has also shown that the protective cover of the connection plate which is made of glass fiber reinforced plastic was not assembled at this system.We point out, that this cover is not assembled as fire protection but a touch protection against electrical shock for the service engineer, due to the high voltage at the gradient cable connectors.What effect this touch protection would have had on the development of the fire cannot be constructed, unfortunately.However, after consulting with experts from different areas it was concluded that that this touch protection has no significant impact on the delay of fire spreading and therefore is not considered as a risk mitigation measure to this effect.Unfortunately, it is not possible to determine why this touch protection was missing at this system.The disassembly/assembly of the gradient connection plate cover is described in the following documents: m7-000.841.16.17 replacement of parts gradient.M6-024.892.01.18 upgrade instruction.M7-010.815.01.22 start-up.Nonetheless, additional risk assessment was conducted to assess the risk of and due to a missing protective cover against electrical shock.Mri technology generally requires strong gradient fields powered by high voltage gradient power amplifiers.This can be taken as common knowledge for service technicians in the field.During manufacturing of the system, it is checked if the protective cover as well as the warning label on the cover are available.With that, for ex-factory systems a missing protective cover can be excluded and only service work during replacement of parts or fit upgrades must be considered.The root causes for a missing plate could be that a distance bolt is missing, and the mounting of the plate is not possible or that the protective cover plate was simply forgotten to be mounted again.For the risk estimation, we point out that beside this protective cover, there are still other means in place which can be considered as protection against electrical shock.These are the cover of the mr system itself and the information in the technical documentation which gives the strict requirement to ensure that the system is always voltage free during the work on electrical components.Further, within the technical documentation it is pointed out that the protective cover must be mounted again to complete the work on the gradient connectors.As of the date of this report, this is the only avanto fit case known where the protective plate was missing, and this has not led to an incident related to an electrical shock.Therefore, it can be assumed that a missing plate is very unlikely in the field and furthermore since we do not have knowledge that a serious adverse event occurred due to unprotected gradient cable connectors at all, the risk identified within this risk assessment can be classified within an acceptable risk area.Nevertheless, to ensure that the protective cover is always mounted the decision to check all avanto fit upgrade systems in the field (following the ui process), as a representative spot check.According to our database and risk assessment there is no accumulation of the described issue seen and no systematic issue is recognizable.A broken cable lug at the gradient cables can cause the vlm to trigger a shutdown, but there are also numerous different indications to recognize a broken cable lug, such as the activation of oscillation monitoring or impaired image quality.These indications do not necessarily trigger the activation of the smoke detector.Prior to this event, a fire due to broken cable lugs at the gradient cables has never been reported to us, and no injuries have ever been reported to us for this reason, which is why we consider the current measures to be suitable and sufficient.This complaint has been closed.Siemens will continue to monitor for this issue.H8: reuse should not have been checked on the initial report submitted to the fda on july 20, 2022.

• Brand Name: MAGNETOM AVANTO FIT
• Common Device Name: 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: 15064247
• Report Number: 3002808157-2022-33725
• Device Sequence Number: 20240920
• Product Code: LNH
• UDI-Device Identifier: 04056869006659
• UDI-Public: 04056869006659
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K220151
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 10849579
• Device Lot Number: 69661
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/23/2022
• Supplement Date Received by Manufacturer: 11/03/2022; 12/21/2022
• Initial Report FDA Received Date: 07/20/2022
• Supplement Report FDA Received Date: 11/04/2022; 12/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown