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

Device Problems Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)

Patient Problem Total Hearing Loss (4473)

Event Type  Injury  

Manufacturer Narrative

Incident date is not known.(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 complained of hearing loss after their mri.The patient was scanned during the week of (b)(6) 2021, for a cervical spine exam with contrast.When the pre-contrast was finished, the mr tech entered the room to give the contrast and the patient informed the tech that the ear plug from the right side and fallen out.The tech told the patient that it was okay and the exam was completed without re-inserting the right side plug.The patient was seen by an ent consultant and a hearing test confirmed that the patient had complete hearing loss on the right side.The patient is currently still under treatment.

Manufacturer Narrative

B4; g1, 3, 6; h2, 3, 6.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.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.The customer was reminded about the appropriate use of ge recommended hearing protection to be used while scanning.No corrections are required as the system was operating within specification.The root cause appears to be inadequate hearing protection.

• Brand Name: SIGNA ARCHITECT
• Type of Device: NUCLEAR MAGNETIC RESONANCE IMAGING
• Manufacturer (Section D): GE MEDICAL SYSTEMS, LLC; 3200 n grandview blvd.; waukesha, WI 53188
• MDR Report Key: 11651582
• MDR Text Key: 246108676
• Report Number: 2183553-2021-00005
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 06/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2021
• 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: 06/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other