MAUDE Adverse Event Report: GE HEALTHCARE MANUFACTURING LLC GE SIGNA ARCHITECT; SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING

Model Number 3T MRI SCANNER

Device Problem Protective Measures Problem (3015)

Patient Problem Superficial (First Degree) Burn (2685)

Event Date 03/31/2022

Event Type  Injury  

Event Description

While undergoing a shoulder mri exam, a patient received a small (5 cmx2 cm) thermal injury (burn) to lateral aspect of chest wall (right side just inferior to patient axilla).The patient was positioned with padding placed between body and scanner bore wall.It is suspected that this area protruded under the padding and touched the bore of the scanner during the test.Patient was evaluated by a physician and determined to have a slight 1st degree burn (light red area).The patient was given instruction for care and to evaluate the area.The patient was contacted 24 hours after the event and informed the facility that the read area has resolved and had no other symptoms.Fda safety report id # (b)(4).

• Brand Name: GE SIGNA ARCHITECT
• Type of Device: SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
• Manufacturer (Section D): GE HEALTHCARE MANUFACTURING LLC
• MDR Report Key: 14137137
• MDR Text Key: 289536275
• Report Number: MW5109084
• Device Sequence Number: 1
• Product Code: LNH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 04/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 3T MRI SCANNER
• Was Device Available for Evaluation?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 57 YR
• Patient Sex: Male
• Patient Weight: 172 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: American Indian Or Alaskan Native