MAUDE Adverse Event Report: GE MEDICAL SYSTEMS, LLC GE 1.5T SIGNA HDX MR SYSTEM; NUCLEAR MAGNETIC RESONANCE IMAGING

Device Problems Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Acoustic Trauma (1694); Tinnitus (2103)

Event Date 09/18/2019

Event Type  Injury  

Manufacturer Narrative

Ge healthcare's investigation is ongoing.A follow up report will be submitted once the investigation has been completed.Device evaluation anticipated, but not yet begun.

Event Description

It was reported via medwatch report # mw5091794, that following an mr exam of the shoulder, a patient complained of an acoustic injury.The patient was evaluated by an ent physician three weeks after the mr exam and was diagnosed with tinnitus and hyperacusis.The patient was prescribed oral steroids which did not resolve the acoustic injury.The patient was provided the alert bulb during the exam, however, the patient never utilized the alert or informed the technologist of any acoustic discomfort or concerns throughout the duration of the exam.The patient was provided headphones with an nrr of 30 which meets ge healthcare's requirements for hearing protection, but the patient stated that they were loose fitting and did not completely cover both ears.

Manufacturer Narrative

The investigation by ge healthcare (gehc) has been completed.This customer does not utilize gehc as their service provider.Gehc has offered to perform acoustic testing measurements on the system, but the customer has declined this offer.The customer does not believe the acoustic output of the mr system is elevated.Based on the information provided, there is no evidence to suggest that the mr systemâ¿¿s acoustic output is above iec 60601-2-33 requirements.It is the customerâ¿¿s responsibility to provide hearing protection for patients with a noise reduction rating (nrr) of greater than 29 db as described in the operator manual.The patient was provided hearing protection, however, there is the potential that the hearing protection may have moved during the exam, in which case the level of hearing protection may have been inadequate.No additional actions are planned by gehc.

• Brand Name: GE 1.5T SIGNA HDX MR SYSTEM
• Type of Device: NUCLEAR MAGNETIC RESONANCE IMAGING
• Manufacturer (Section D): GE MEDICAL SYSTEMS, LLC; 3200 n grandview blvd.; waukesha, WI 53188
• MDR Report Key: 9638844
• MDR Text Key: 176681311
• Report Number: 2183553-2020-00003
• Device Sequence Number: 1
• Product Code: LNH
• Combination Product (y/n): N
• PMA/PMN Number: K052293
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 03/10/2020

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
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/03/2020
• Initial Date FDA Received: 01/28/2020
• Supplement Dates Manufacturer Received: 02/12/2020
• Supplement Dates FDA Received: 03/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 48 YR
• Patient Weight: 83