MAUDE Adverse Event Report: GE MEDICAL SYSTEMS, LLC 3.0T SIGNA HDXT; NUCLEAR MAGNETIC RESONANCE IMAGING

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

Patient Problems Hearing Impairment (1881); Hearing Loss (1882)

Event Date 01/11/2019

Event Type  Injury  

Manufacturer Narrative

Unique identifier: udi not required.There are no additional device identification numbers.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 that a patient who underwent an mri complained of hearing impairment after the exam.The patient was provided hearing protection (head phones) for the exam.The patient was seen by a physician who confirmed hearing loss.Treatment was provided, however the actual treatment is unknown.

Manufacturer Narrative

H3: the investigation by ge healthcare has been completed.The acoustic performance of the scanner was tested, and it was found to be within regulatory limits.No system issue was found.It is the customers responsibility to provide hearing protection for the 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, it was inadequate to protect them from the acoustic noise.Ge reviewed the recommended hearing protection as stated in the operator manual with the customer.No corrections are required as the system was operating within specification.The root cause appears to be inadequate hearing protection.

• Brand Name: 3.0T SIGNA HDXT
• Type of Device: NUCLEAR MAGNETIC RESONANCE IMAGING
• Manufacturer (Section D): GE MEDICAL SYSTEMS, LLC; 3200 n grandview blvd.; waukesha, WI 53188
• MDR Report Key: 8914015
• MDR Text Key: 155006456
• Report Number: 2183553-2019-00016
• Device Sequence Number: 1
• Product Code: LNH
• Combination Product (y/n): N
• PMA/PMN Number: K121676
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2019
• 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
• Date Manufacturer Received: 09/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 67 YR