MAUDE Adverse Event Report: GE GE EXCITE HDX 1.5T MR; MRI SCANNER SYSTEM NUCLEAR MAGNETIC RESONANCE IMAGING

Device Problems Loose or Intermittent Connection (1371); Overheating of Device (1437)

Patient Problem Burn, Thermal (2530)

Event Date 07/18/2017

Event Type  No Answer Provided  

Event Description

A patient received a burn on her arm after the mri was done.Both of the patient's arms were padded.When removing the patient after the exam was completed, she stated her arm was hot.About an hour later, a nurse entered the department and stated the patient had a burn.Service was called to evaluate the equipment.Equipment service update: equipment being serviced.Ge excite hdx 1.51 mr.Reported problem: customer needs to report a patient burn.Action plan: checked patient images, noted what appears to be a coil loading issue.Checked rf max out, peaked rf waveform, found multiple loose rf connections which could have caused the rf peak to flatten increasingly susceptibility to heating.Performed t/r dynamic disable cal.Ran snr on both head and body, had noticable increases on snr values.Noted patient positioning skewed in bore, both burns being on the right side indicates rf coil contact.Will monitor site.

• Brand Name: GE EXCITE HDX 1.5T MR
• Type of Device: MRI SCANNER SYSTEM NUCLEAR MAGNETIC RESONANCE IMAGING
• Manufacturer (Section D): GE
• MDR Report Key: 6739910
• MDR Text Key: 81014127
• Report Number: MW5071193
• 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: 07/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• 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: 85 YR
• Patient Weight: 114