MAUDE Adverse Event Report: GE HANGWEI MEDICAL SYSTEMS CO., LTD. GE MRI SCAN; SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING

Model Number SIGNA HD

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Erythema (1840); Burning Sensation (2146)

Event Date 09/01/2022

Event Type  Injury  

Event Description

Patient warming event from mri scan.Left hip warming/redness.Fda safety report id #(b)(4).

• Brand Name: GE MRI SCAN
• Type of Device: SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
• Manufacturer (Section D): GE HANGWEI MEDICAL SYSTEMS CO., LTD.
• MDR Report Key: 15428452
• MDR Text Key: 300210530
• Report Number: MW5112067
• Device Sequence Number: 1
• Product Code: LNH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SIGNA HD
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 27 YR
• Patient Sex: Male
• Patient Weight: 77 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White