Initial report was received by siemens on april 15, 2021 via fda maude report mw5100274.Siemens contacted patient for additional information regarding the event, which was received.Patient information is being kept confidential.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.
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It was reported to siemens that a patient suffered a hearing loss during mr examination.The patient had been wearing a plastic headset but no earplugs during examination.Immediately after mr examination patient noticed hearing changes including muffled hearing, ringing in the ears, ear pain, sound sensitivity, pressure and warmth inside of both ears.Patient informed the technician after examination about it.The patient's hearing issues did not subside and the patient followed up with two ent physicians for examination and treatment.It was reported that the physicians were not able to provide the patient with any treatment options and the symptoms are now chronic.
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Siemens received an fda maude report that a patient complained about symptoms of muffled hearing, ringing in the ears, ear pain and sound sensitivity after hip examination.The patient's hearing issues did not subside and the patient followed up with two ent physicians for examination and treatment.The physicians were not able to provide the patient with any treatment options and the patient still had symptoms of discomfort and tinnitus.It was stated in the maude report that only a pair of plastic headphones was applied to the patient to protect hearing and no other equipment like earplugs were provided.Generally, the maximum acoustic noise at magnetom verio systems measured according to the nema standard is 115,4db(a).That measurement procedure includes the search for the loudest spot.The position of the ear in this set up (hip examination with hip at isocenter) is about at the end of the bore.That position was tested in the nema procedure, and it was identified as the loudest position.As the nema measurement was done with the mgan option, which is looking for the loudest technical sequence protocol, all real imaging sequence protocols will be significantly less loud.The consequence of the nema result of 115,4db is that - adding a safety margin - a hearing protection of minimum 20db needs to be applied to the patient.Ear plugs with a noise attenuation coefficient equal or greater than the required hearing protection are considered suitable hearing protection.The magnetom family operator manual* - mr system, syngo mr b19 (page 29-31) and the magnetom verio system owner manual** (page 11) provide instructions and warnings regarding noise levels and the respective hearing protection required.The headphones provided by siemens mr are not classified as hearing protectors.Their primary use is to provide a channel of communication between the mr operator and the patient.The headphones may be used to provide additional noise attenuation for increased patient comfort, to enable listening to music, etc.Using both earplugs and headphones does not hinder communication with the patient.The volume level on the patient intercom should be increased to medium or high to ensure clear communication.Assessment of the reported incident does not indicate a system failure or malfunction and no non-conformity was identified.It seems that the patient did not wear appropriate hearing protections, so we conclude that the root cause was a user error.
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