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

Model Number	10432915
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Codes	Hearing Impairment (1881); Partial Hearing Loss (4472)
Date of Event	04/10/2024
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
It was reported to siemens that an adverse event occurred while operating the magnetom skyra mr system.It was reported that a patient complained of hearing loss after a scan.The patient had an audiogram soon after the event, however, no further information about the patient's health status has been received.Therefore, an in-doubt reporting will be performed.
Additional Manufacturer Narrative
For the investigation, siemens healthineers requested the respective save logs, sequences and quality assurance (qa) check results.The customer has accepted that they made a mistake in scanning the patient without any hearing protection and they have no reason to suspect any failure of the equipment.Therefore, no further investigation of this issue is possible.We assess this incident as user error because the patient was not given adequate hearing protection.The magnetom aera, skyra operator manual ¿ mr system syngo mr d13 (order no.M7-01001.621.04.01.02 page a.2-18.) explicitly warns that noise development during an mr examination may lead to hearing impairment up to permanent hearing loss.It is explained that by switching the currents in the gradient coils for imaging purposes, the mechanical forces lead to noise development (humming, knocking noises) during the mr examination which can exceed 99 db(a) in the bore.The patient is to be provided with appropriate hearing protection that lowers noise to at least 99 db(a).The system specific technical data are detailed in the magnetom skyra system owner manual ¿ 5 technical data (print no.M7-01002.629.05.02.02 page 7).There it is stated that the a-evaluated, effective sound pressure level was measured according to nema ms 4-2010 (national electrical manufacturers association) using the maximum gradient acoustic noise (mgan) method.For the systems with xq gradients patients require hearing protection of 22db or more.We recommend the use of earplugs to achieve an appropriate level of attenuation to avoid hearing problems.The standard siemens mri headphones are intended for communication with the patient and can be used in combination with ear plugs.For appropriate sound attenuation, the proper use of hearing protection is important.All personnel are to be trained to correctly apply the hearing protection.

• Brand Name: MAGNETOM SKYRA
• Common Device Name: 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: jenna keefe ; 40 liberty blvd; malvern, PA 19355 ; 4843234206
• MDR Report Key: 20046025
• Report Number: 3002808157-2024-00013
• Device Sequence Number: 12746113
• Product Code: LNH
• UDI-Device Identifier: 04056869006703
• UDI-Public: (01)04056869006703
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K231560
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/03/2024

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: 10432915
• Device Catalogue Number: 10432915
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/09/2024
• Supplement Date Received by Manufacturer: 11/19/2024
• Initial Report FDA Received Date: 08/23/2024
• Supplement Report FDA Received Date: 12/03/2024
• 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: A
• Patient Sequence Number: 1
• Patient Age: 55 YR
• Patient Sex: Unknown