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

Model Number 10836618

Device Problem Use of Device Problem (1670)

Patient Problem Hearing Impairment (1881)

Event Date 11/17/2021

Event Type  Injury  

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 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.

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.

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
• Type of Device: 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
• MDR Text Key: 299872901
• Report Number: 3004754211-2022-43844
• Device Sequence Number: 1
• Product Code: LNH
• UDI-Device Identifier: 04056869006789
• UDI-Public: 04056869006789
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K161795
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: 10836618
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/07/2022
• Initial Date FDA Received: 09/14/2022
• Supplement Dates Manufacturer Received: 09/15/2022; 11/02/2022
• Supplement Dates FDA Received: 09/15/2022; 11/02/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 73 YR
• Patient Sex: Female