MAUDE Adverse Event Report: GE MEDICAL SYSTEMS, LLC DISCOVERY MR750W 3.0T; NUCLEAR MAGNETIC RESONANCE IMAGING

Device Problems Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Tinnitus (2103); Partial Hearing Loss (4472)

Event Date 03/03/2021

Event Type  Injury  

Manufacturer Narrative

Unique identifier: (b)(4).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 experienced hearing loss that progressed to tinnitus following a brain mri/mra exam.The patient was supplied with the standard facility ear plugs, but stated that the system was still loud.The patient squeezed the alert bulb and at that point, the technologists placed additional pads between his ears and the inside of the head coil.The patient elected to complete the exam noting that the sound was decreased with the additional padding in place.The patient's hearing loss has almost completely subsided, but the tinnitus remains.The patient was fitted for a tinnitus ear bud but has elected not to wear the device.

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: DISCOVERY MR750W 3.0T
• Type of Device: NUCLEAR MAGNETIC RESONANCE IMAGING
• Manufacturer (Section D): GE MEDICAL SYSTEMS, LLC; 3200 n grandview blvd.; waukesha, WI 53188
• MDR Report Key: 11806717
• MDR Text Key: 250613501
• Report Number: 2183553-2021-00006
• Device Sequence Number: 1
• Product Code: LNH
• Combination Product (y/n): N
• PMA/PMN Number: K163331
• 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: 07/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2021
• 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: 06/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 46 YR
• Patient Weight: 72