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

Model Number 11291455

Device Problems Device Handling Problem (3265); Noise, Audible (3273)

Patient Problems Tinnitus (2103); Unspecified Mental, Emotional or Behavioural Problem (4430)

Event Date 03/11/2021

Event Type  Injury  

Manufacturer Narrative

H3, h6: the investigation is ongoing.A supplemental report will be submitted if additional information becomes available upon completion of the investigation.

Event Description

Per the complaint report, received by siemens healthineers on 2023-05-16, it was stated that patient had tinnitus before the mri examination on (b)(6) 2021 and he claimed that the mri examination made the tinnitus worse.In addition, the patient is complaining that the tinnitus is causing other mental health issues.This event reflects a permanent health impact and serious injury.Per the complaint report siemens healthineers received the following information: patient was wearing earplugs and headphones at the beginning of the examination patient removed headphones himself after hearing "screech" noise through the headphones patient did not press the squeeze ball during examination patient has been seen by hospital consultants who were unable to find any issues according to a review of the complaint handling system, no further similar incidents occurred with this system since this incident on (b)(6) 2021.The issue occurred over two years ago.Complainant stated that save log, dicom images, system qa, qa of the affected coil of the time of the incident are not available for an adequate problem investigation.Information regarding patient health status, system history and additional information supporting the problem investigation were requested, and are pending receipt as of the date of this report.

Manufacturer Narrative

Siemens attempted to investigate the reported incident but was informed that two years after the incident occurred no data is available for an investigation (no a save log, no dicom images, no system quality assurance tests (qa) and no qa of the affected local coil of the time of the incident).According to the information provided to us the patient suffered from a constant roaring and screeching in his ears after the mri scan and the noise has not abated with time.There is no update available regarding the current health status of the patient as the hospital is no longer in contact with the patient.The facility has not received any complaints regarding this issue from any other patient in nearly two years after this incident happened.This is confirmed by an analysis of the complaint data bases which show that no further similar incidents occurred at this customer site with this customer system since this incident on (b)(6) 2021.The customer was provided with the information in the owners and user's manual with regard to hearing protection as well as the part number of the patient headphones as requested.

• Brand Name: MAGNETOM SOLA
• Type of Device: 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: anastasia sokolova ; 40 liberty blvd.; 65-1a; malvern, PA 19355 ; 4843234198
• MDR Report Key: 16962868
• MDR Text Key: 315571605
• Report Number: 3002808157-2023-72957
• Device Sequence Number: 1
• Product Code: LNH
• UDI-Device Identifier: 04056869164809
• UDI-Public: 04056869164809
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K220425
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 11291455
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/22/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Disability