MAUDE Adverse Event Report: GE HEALTHCARE MANUFACTURING LLC GE 1.5 TESLA SIGNA EXCITE ; SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING

Device Problem Protective Measures Problem (3015)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/06/2019

Event Type  No Answer Provided  

Event Description

Mri safety incident.Pt was properly screened with form and verbally prior to entering mri scan room for mri rt shoulder.Once localizer was obtained a metallic foreign body was noted on anterior rt shoulder superficially.Technologist informed mrso immediately.Mrso directed technologist to check pt's gown and coil to make sure nothing metallic was on them.Tech confirmed and removed headphones per mrso.Tech scanned localizer again and artifact was still present.Radiologist was called and looked at localizer images.The radiologist was informed pt had previous mri cervical at same facility prior to the test with no issues.Radiologist found ct chest from another facility and stated the foreign body was too small and superficial to be worrisome and gave authority to continue the exam.Pt did not experience any issues.Fda safety report id # (b)(4).

• Brand Name: GE 1.5 TESLA SIGNA EXCITE
• Type of Device: SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
• Manufacturer (Section D): GE HEALTHCARE MANUFACTURING LLC
• MDR Report Key: 9075741
• MDR Text Key: 158982278
• Report Number: MW5089812
• 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: 09/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 57 YR
• Patient Weight: 100