MAUDE Adverse Event Report: SIEMENS HEALTHINEERS AG MAGNETOM AVANTO; SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING

Model Number	07391167
Medical Device Problem Codes	Device-Device Incompatibility (2919); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	06/17/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Siemens healthineers was notified of an issue associated with the magnetom avanto system.During a review of the fda maude database performed by siemens healthineers mr team, medwatch mw5156536 was identified.The medwatch report stated a patient sustained 2nd degree (partial thickness) burns to his chest from 3m electrodes #2570 connected to ekg (electrocardiogram) leads during the mri examination on (b)(6) 2024.The medwatch report also referenced report mw5156537; however, when searched, this report was not available in the maude database search.The medwatch report did not contain any further information.The reporting facility, system serial number, facility contact name and phone number, severity of the patient injury, and any medical treatment that may have been provided to the patient were not contained in the medwatch report.The event was not reported directly to siemens healthineers; therefore, additional information cannot be obtained.
Additional Manufacturer Narrative
D4: without a system serial number, a complete udi could not be reported.E1: the facility name and contact information were not provided in mw5156536.H3, h6: without the facility name, contact information, or the system serial number, siemens healthineers could not perform an investigation of the reported event.Nevertheless, the magnetom family operator manual ¿ mr system (e.G., syngo mr b19, print no.Mr-01501g.621.01.02.02, as the system's software version is unknown) clearly states that only mr compatible monitoring devices must be used: ¿use only monitoring devices, for example, ecg electrodes and pulse sensor, that meet the conditions for safe use (mr safe or mr conditional).¿ according to the manufacturer reference guide, the 3m¿ red dot¿ cardiac monitoring electrode 2570 is mr conditional.However, without additional information it is unknown if the conditions were met.Furthermore, the reference guide states: ¿the 3m¿ red dot¿ ecg electrode that underwent mri testing was not connected to an electrocardiograph (ecg) lead and/or an mr conditional monitoring system.Therefore, the safety of using this 3m red dot ecg electrode attached to an ecg lead and/or mr conditional monitoring system is unknown.Furthermore, an mr conditional monitoring system typically requires use only with ecg electrodes specifically designed and tested with that specific equipment.It is unknown if this 3m red dot ecg electrode is acceptable for use with an mr conditional ecg monitoring system designed to be used to monitor a patient undergoing an mri procedure.¿ unfortunately, without any additional information the root cause for the patient's burn could not be identified.This complaint has been closed.
Additional Manufacturer Narrative
H3, h6: siemens attempted to further investigate the reported event, associated system, electrodes, facility, and additional patient information/health status.Per mw5156536, a patient has 2nd degree burns to the chest area from 3m electrodes #(b)(4) connected to ekg (electrocardiogram) leads during an mri examination.Date of event is (b)(6) 2024.The report also references report mw5156537, which was not identified during maude database search.Unfortunately, confirmation of the system material number, serial number, and information about the reporting health facility could not be identified during the investigation.Therefore, no additional information or data regarding the reported event could be obtained and the complaint was closed without any further investigation.The h6 codes reported in the initial report have not changed.Nevertheless, the magnetom family operator manual ¿ mr system, since the system's software version is unknown, was reviewed and clearly states that only mr compatible monitoring devices must be used: - use only monitoring devices, for example, ecg electrodes and pulse sensor, that meet the conditions for safe use (mr safe or mr conditional).According to the manufacturer reference guide, the 3m¿ red dot¿ cardiac monitoring electrode (b)(4) is mr conditional.However, without additional information it is unknown if the conditions were met.Furthermore, the reference guide states: - this 3m¿ red dot¿ ecg electrode that underwent mri testing was not connected to an electrocardiograph (ecg) lead and/or an mr conditional monitoring system.Therefore, the safety of using this 3m red dot ecg electrode attached to an ecg lead and/or mr conditional monitoring system is unknown.Furthermore, an mr conditional monitoring system typically requires use only with ecg electrodes specifically designed and tested with that specific equipment.It is unknown if this 3m red dot ecg electrode is acceptable for use with an mr conditional ecg monitoring system designed to be used to monitor a patient undergoing an mri procedure.Unfortunately, without any additional information the root cause for the patient's burn could not be identified.

• Brand Name: MAGNETOM AVANTO
• Common Device Name: SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
• Manufacturer (Section D): SIEMENS HEALTHINEERS AG; allee am röthelheimpark 2; erlangen 91052 ; GM 91052
• Manufacturer (Section G): SIEMENS HEALTHINEERS AG; allee am röthelheimpark 2; erlangen 91052 ; GM 91052
• Manufacturer Contact: rebecca tudor ; 40 liberty blvd., mc 65-1a; malvern, PA 19355 ; 4843234198
• MDR Report Key: 19816228
• Report Number: 3002808157-2024-00011
• Device Sequence Number: 8665431
• Product Code: LNH
• UDI-Device Identifier: 04056869006611
• UDI-Public: (01)04056869006611
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K181613
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/24/2024

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
• Operator of Device: Health Professional
• Device Model Number: 07391167
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/11/2024
• Supplement Date Received by Manufacturer: 09/24/2024
• Initial Report FDA Received Date: 07/24/2024
• Supplement Report FDA Received Date: 09/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 72 YR
• Patient Sex: Male