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

Model Number	7391167
Health Effect - Clinical Code	Acoustic Shock (1693)
Date of Event	03/07/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
On july 4, 2022, it was reported to siemens that a patient complained the magnetom avanto system noise level during examination was too high, even with the hearing protection supplied by the technologist.The patient alleged that the noise during the exam caused him pain and hyperacusis.The patient affirmed the issues are persisting.The reported event occurred in (b)(6).
Additional Manufacturer Narrative
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.
Additional Manufacturer Narrative
H10: siemens completed the investigation of the reported event.It was reported that a patient complained that the noise level during examination was too high even with the hearing protection supplied by the technologist.The patient alleged that the noise during the exam caused him pain and hyperacusis.The patient affirmed the issues are persisting.The customer protocols of the patient's examination were tested inhouse by siemens on a similar magnetom avanto system with identical software.The acoustic noise report for avanto sq and q engine (b)(4) consider the maximum noise level according to iec 60601-2-33 edition 3 paragraph 201.9.6.2.1 audible acoustic energy, using the method described by nema ms 4-2006 (national electrical manufacturers association): "acoustic noise measurement procedure for diagnostic magnetic resonance imaging devices".Our experts determined all measured noise values were below the specified maximum noise level of the mr system.The loudest noise of loudest sequence at loudest spot inside the patient bore was laeq = 107,2db(a) and lpeak = 112,5dbpeak.As stated in the magnetom avanto operator manual* - mr system syngo mr b19 (page a.2-19 / a.2-20) and the magnetom avanto system owner manual (page a.1-11) patients shall be provide with appropriate hearing protection that lowers noise to at least 99 db(a).Both manuals provide clear instructions and warnings regarding noise levels and the respective hearing protection required.Ear plugs with a noise attenuation coefficient equal or greater than the required hearing protection are considered suitable hearing protection.According to our information the patient wore earplugs with 29db attenuation.This should be sufficient for the safety of the patient.Furthermore, the mr system was checked and found to be in specification.The root cause for the persisting hyperacusis could not be determined.Later, siemens was informed that the patient still suffers of hyperacusis but after discussion with the specialist who requested the exam, it could be caused by the patient's preexisting condition (reason for the requested exam).This complaint has been closed.Order no.M6-02001.621.09.01.02.Print no.M6-02002.629.08.01.02.E4: additional information confirmed that the customer did not report the event to the fda.D8: additional information confirmed the system was not serviced by a third party.H8: the usage of device was checked as "reuse" in the initial report submitted on july 14, 2022.This should not have been checked.

• Brand Name: MAGNETOM AVANTO
• 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: 15013063
• Report Number: 3002808157-2022-35431
• Device Sequence Number: 6856319
• Product Code: LNH
• UDI-Device Identifier: 04056869006611
• UDI-Public: 04056869006611
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K181613
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/21/2022

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
• Operator of Device: Health Professional
• Device Model Number: 7391167
• 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: 07/04/2022
• Supplement Date Received by Manufacturer: 12/20/2022
• Initial Report FDA Received Date: 07/14/2022
• Supplement Report FDA Received Date: 12/21/2022
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown