MAUDE Adverse Event Report: GE HEALTHCARE JAPAN CORPORATION SIGNA PIONEER; NUCLEAR MAGNETIC RESONANCE IMAGING

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)

Patient Problem Hearing Loss (1882)

Event Date 03/11/2016

Event Type  Injury  

Manufacturer Narrative

Ge healthcare's investigation is ongoing.A follow-up report will be submitted once the investigation has been completed.

Event Description

The customer reported that a patient underwent a gad brain scan.The patient was given earbuds for music.After the scan was completed the patient complained of hearing loss.A physician confirmed that the patient sustained a bilateral sensorineural hearing loss.

Manufacturer Narrative

Ge healthcare's investigation confirmed that the pioneer ((b)(4)) system limits acoustic noise when hearing protection is used.The system operator is responsible for providing the hearing protection.In this case, hearing protection was provided and placed by the patient.The system acoustic level was tested to meet local regulations.This gradient was removed and replaced with a new gradient based on customer satisfaction concerns.

• Brand Name: SIGNA PIONEER
• Type of Device: NUCLEAR MAGNETIC RESONANCE IMAGING
• Manufacturer (Section D): GE HEALTHCARE JAPAN CORPORATION; 7-127, asahigaoka 4-chome; hino-shi 191-8 503; JA 191-8503
• Manufacturer (Section G): GE HEALTHCARE JAPAN CORPORATION; 7-127, asahigaoka 4-chome; hino-shi 191-8 503; JA 191-8503
• Manufacturer Contact: brad wheeler ; 3000 n. grandview blvd., w450; waukesha, WI 53188
• MDR Report Key: 5692008
• MDR Text Key: 46313639
• Report Number: 9612283-2016-00002
• Device Sequence Number: 1
• Product Code: LNH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K143345
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/24/2016
• 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
• Patient Age: 36 YR
• Patient Weight: 93