MAUDE Adverse Event Report: GE HEALTHCARE (TIANJIN) COMPANY LIMITED SIGNA ARTIST; NUCLEAR MAGNETIC RESONANCE IMAGING

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Output Problem (3005)

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

Event Date 10/27/2021

Event Type  Injury  

Event Description

It was reported that a patient who underwent an mri of the thoracic and lumbar spine stated that the system was very loud.The patient was provided hearing protection.The patient was seen by an ent and had confirmed tinnitus and hearing loss.The patient is currently undergoing steroid treatment.

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.

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.The incident appears to be the result of human medical condition(s).The patient was provided specified hearing protection during the scan.Human condition 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: SIGNA ARTIST
• Type of Device: NUCLEAR MAGNETIC RESONANCE IMAGING
• Manufacturer (Section D): GE HEALTHCARE (TIANJIN) COMPANY LIMITED; no.266 jingsan road,; tianjin airport economic area; tianjin 30030 8; CH 300308
• Manufacturer (Section G): GE HEALTHCARE (TIANJIN) COMPANY LIMITED; no.266 jingsan road,; tianjin airport economic area; tianjin 30030 8; CH 300308
• Manufacturer Contact: andy koch ; 3200 n. grandview blvd.; waukesha, WI 53188
• MDR Report Key: 13167812
• MDR Text Key: 283244302
• Report Number: 3010949642-2022-00001
• Device Sequence Number: 1
• Product Code: LNH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K202238
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/10/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/29/2019
• 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: 74 YR
• Patient Sex: Male
• Patient Weight: 225 KG