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

Device Problems Device Slipped (1584); Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Tinnitus (2103)

Event Date 08/01/2017

Event Type  Injury  

Manufacturer Narrative

Patient information could not be provided due to country privacy laws.There are no additional device identification numbers.(b)(6).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 following a mr exam of the pelvis, the patient experienced symptoms of tinnitus.The patient stated that they were evaluated by a physician and diagnosed with tinnitus.The patient underwent five days of steroid treatments.However, the treatment did not improve or resolve the condition.The customer stated that ear plugs were provided, but that they had partially slid out of the patient's ears during the exam.

Manufacturer Narrative

Ge healthcare¿s investigation has been completed.The 1.5t hdxt system limits acoustic noise when hearing protection is used.The system operator is responsible for providing the hearing protection and proper usage guidance.In this case, hearing protection was provided but partially slid out of the patient's ears during the exam.The system acoustic testing concluded that the scanner meets iec & osha levels and is within the specification for this system configuration.No systemic issue was found.No corrections are required as the system was operating within specification.The root cause of the injury appears to be inadequate hearing protection.

• Brand Name: 1.5T SIGNA HDXT
• Type of Device: NUCLEAR MAGNETIC RESONANCE IMAGING
• Manufacturer (Section D): GE MEDICAL SYSTEMS, LLC; 3200 n grandview blvd.; waukesha, WI
• Manufacturer Contact: jacqui budde ; 3200 n. grandview blvd.; waukesha, WI
• MDR Report Key: 6866965
• MDR Text Key: 86250491
• Report Number: 2183553-2017-00019
• 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: 10/10/2017

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
• Other Device ID Number: UDI NOT REQUIRED
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/22/2017
• Initial Date FDA Received: 09/14/2017
• Supplement Dates Manufacturer Received: 09/28/2017
• Supplement Dates FDA Received: 10/10/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/1970
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other