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).
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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.
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