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

Model Number 10276755

Device Problem Use of Device Problem (1670)

Patient Problems Concussion (2192); Injury (2348); Patient Problem/Medical Problem (2688)

Event Date 06/11/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).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.Resubmission of initial report due to report code error.

Event Description

It was reported to siemens that an adverse event occurred following use of the magnetom verio system.The user reported that a patient complained of a possible concussion and hearing loss after an mri examination.The patient was instructed to be evaluated in the emergency room.It was later reported that the patient left the hospital.It is not known what treatment was being administered or the patients condition prior to examination.Additional information has been requested regarding the patients condition, however, no further details have been made available at this time.

Manufacturer Narrative

Siemens has completed an investigation of the reported event.Assessment of the reported incident does not indicate a system failure or malfunction and no non-conformity was identified.The root cause was determined to be user error.Siemens requested additional information related to the reported complaint in order to conduct an investigation.The defective head phones were replaced and not returned for evaluation.The root cause for the fractured material could not be determined, however, it was reported that ear plugs were not used during this examination.For safety reasons, appropriate hearing protection needs to be provided to the patient.The magnetom operator manual and the magnetom system owner manual provide instructions and warnings regarding noise levels and the respective hearing protection required (section "hearing protection data").Ear plugs with a noise attenuation coefficient equal or greater than the required hearing protection are considered suitable hearing protection.The required level of hearing protection can be found in the system owner manual of each mr system.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.The manufacturer is not considering further actions resulting from this event as no systematic error has been recognized.

• Brand Name: MAGNETOM VERIO
• Type of Device: SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; henkestrasse 127; erlangen, germany 91052 ; GM 91052
• MDR Report Key: 8482549
• MDR Text Key: 140900782
• Report Number: 3002808157-2018-34569
• Device Sequence Number: 1
• Product Code: LNH
• Combination Product (y/n): N
• PMA/PMN Number: K072237
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Remedial Action: Repair
• Type of Report: Initial,Followup
• Report Date: 07/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 10276755
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 05/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other