MAUDE Adverse Event Report: GE MEDICAL SYSTEMS, LLC OPTIMA MR450W 1.5T; NUCLEAR MAGNETIC RESONANCE IMAGING

Device Problems Unintended Magnet Quench (1377); Device Operates Differently Than Expected (2913); Noise, Audible (3273)

Patient Problems No Information (3190); No Code Available (3191)

Event Date 08/10/2017

Event Type  Injury  

Manufacturer Narrative

Patient information has been requested but not yet received.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.

Event Description

It was reported that a patient was undergoing a brain laser ablation procedure when a magnet quench occurred.The patient had holes opened in his skull, and preliminary scanning had just completed.The staff entered the room and were preparing to proceed with the laser ablation portion of the procedure when they heard a hiss sound from the magnet.The magnet quenched properly through the vent pipe, and no helium vented into the room.The procedure could not be completed.The patient was moved back into the surgical suite and brought to recovery.The patient will most likely have to return to have the procedure completed at a later date.

Manufacturer Narrative

The investigation by ge healthcare (gehc) has been completed.All system components were reviewed and no external causes were found for the quench.Additionally, the surgical suite was operating correctly and as intended.The quench was a spontaneous quench.A quench is a very real possibility on all superconducting magnets (not just ge) and it is essential to plan and protect against it.Gehc already has the appropriate features in place to vent and safely quench a magnet.All of those features worked as designed.The site's magnet is back up and fully functional.All calibrations and checks were completed without issue.Received maude report # mw5072030.

• Brand Name: OPTIMA MR450W 1.5T
• Type of Device: NUCLEAR MAGNETIC RESONANCE IMAGING
• Manufacturer (Section D): GE MEDICAL SYSTEMS, LLC; 3200 n grandview blvd.; waukesha WI
• Manufacturer Contact: jacqui budde ; 3200 n. grandview blvd.; waukesha, WI
• MDR Report Key: 6840234
• MDR Text Key: 84614907
• Report Number: 2183553-2017-00018
• Device Sequence Number: 1
• Product Code: LNH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K132376
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Medical Technologist
• Type of Report: Initial,Followup
• Report Date: 11/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Other Device ID Number: UDI_NOT_REQUIRED
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/08/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/1970
• 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: 47 YR
• Patient Weight: 119