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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hearing Loss (1882); Tinnitus (2103)

Event Date 03/06/2019

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 via maude report # mw5084711 that a patient was provided a music headset prior to a right knee scan.During the exam, the patient used the alert ball and stated that the scanner was too loud.At that time, the customer provided the patient with ear plugs in combination with the previously provided headphones.Following the scan, the patient reported new ringing and decreased hearing in her right ear.On 18 april 2019, the patient stated that she underwent a hearing test on (b)(6) 2019.The results of the test showed a new hearing deficit in the right ear when compared to a previous hearing test from (b)(6) 2018.To date, her hearing has not improved and she has been prescribed hearing aids.

Manufacturer Narrative

H3: the investigation by ge healthcare has been completed.The acoustic performance test was performed on the system and concluded that the testing meets the iec 60601-2-33 requirements and the osha levels are within the specification for this system configuration.The incident appears to be the result of human medical condition(s).The patient was provided specified hearing protection, however a patient's medical conditions may cause sensitivity to acoustic levels that occur during normal clinical scanning.No system issue was found.No corrections are required as the system was operating within specification.

• 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: 8596584
• MDR Text Key: 144655492
• Report Number: 2183553-2019-00009
• 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,health
• Type of Report: Initial,Followup
• Report Date: 07/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2019
• 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: 06/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other