MAUDE Adverse Event Report: SIEMENS SHENZHEN MAGNETIC RESONANCE LTD. MAGNETOM ESSENZA DOT UPGRADE; SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING

Model Number	10836618
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Hearing Impairment (1881)
Date of Event	11/17/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A facility contact name was not provided for reporting.No allegation of complaint was made regarding the reported system.The patient reportedly was not provided with hearing protection during the examination.Siemens is attempting to obtain additional information from the patient.If additional reportable information is received by siemens, a supplemental report will be submitted.
Event or Problem Description
It was reported a patient underwent a mr examination on (b)(6) 2021, and has suffered persistent tinnitus since then.The patient did not wear headphones or earplugs and no other hearing protection was provided.As of the date of this report, additional information from the patient is being clarified.It is unclear if the tinnitus is temporary or permanent.The reported event occurred in japan.
Additional Manufacturer Narrative
Additional information: the system owner manual (mr-04009.623.07.03.02, section 1.4.1) and operator manual (m4-06001.621.08.03.02, section 1.4.1) for the magnetom essenza system both state that hearing protection must be provided to patients and personnel must be trained to correctly apply the hearing protection.
Additional Manufacturer Narrative
Siemens investigated the reported event.Due to data privacy, siemens could not obtain additional information regarding the patient's physical state information regarding a medical diagnosis of tinnitus severity, medical history, or related additional medical treatment received after the examination.It was confirmed by the customer service engineer that the patient was not wearing headphones or earplugs during the examination, and no other hearing protection was provided.The complaint mr system was evaluated and found to be functioning within specification.As stated in the magnetom essenza operator manual (doc id is m4-06001.621.08.03.02) (page 25) and system owner manual (doc id is mr-04009.623.07.03.02) (page 11), patients shall be provided with appropriate hearing protection that lowers noise to at least 99 db(a).Generally, the maximum sound value at the magnetom essenza system measured is 110.5 db(a) and 116.8db peak.For safety reasons, hearing protectors with a noise attenuation of at least 18 db needs to be applied to the patient.The user manuals provide clear instructions and warnings regarding noise levels and the respective hearing protection required.Based on above analysis, no evidence indicate that patient tinnitus was caused by a system malfunction.More suspect is that there was no hearing protection provided to the patient during the mr examination.Siemens reminded the reporting facility that the user shall comply with operation manual to provide patient with the correct hearing protection during mr examination.This complaint has been closed.Additional action by siemens is not deemed necessary.

• Brand Name: MAGNETOM ESSENZA DOT UPGRADE
• Common Device Name: SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
• Manufacturer (Section D): SIEMENS SHENZHEN MAGNETIC RESONANCE LTD.; siemens mri, gaoxin c ave.; 2nd, hi-tech industrial park; shenzhen, 51805 7; CH 518057
• Manufacturer (Section G): SIEMENS SHENZHEN MAGNETIC RESONANCE LTD.; gaoxin c ave.; 2nd, hi-tech industrial park; shenzhen, 51805 7; CH 518057
• Manufacturer Contact: rebecca tudor ; 40 liberty blvd.; 65-1a; malvern, PA 19355 ; 4843234198
• MDR Report Key: 15419272
• Report Number: 3004754211-2022-43844
• Device Sequence Number: 16840468
• Product Code: LNH
• UDI-Device Identifier: 04056869006789
• UDI-Public: 04056869006789
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K161795
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/02/2022

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: 10836618
• 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: 09/07/2022
• Supplement Date Received by Manufacturer: 09/15/2022; 11/02/2022
• Initial Report FDA Received Date: 09/14/2022
• Supplement Report FDA Received Date: 09/15/2022; 11/02/2022
• 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 Age: 73 YR
• Patient Sex: Female