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

Device Problems Fire (1245); Smoking (1585); Device Misassembled During Manufacturing /Shipping (2912)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 10/11/2018

Event Type  malfunction  

Manufacturer Narrative

Unique identifier: (b)(4).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 to ge healthcare that the customer was in between scans, prepping the patient, when the technologist noticed smoke and a flame at the back of the scanner.The technologist pressed the emergency off, the examination was stopped, and the patient was removed from the scanner.The technologist then used an extinguisher to put out the flame.The ge field engineer was called and initial investigation found that the y gradient lead had arced leading to localized damage.No injury occurred.

Manufacturer Narrative

The investigation by ge healthcare (gehc) has been completed and concluded that the "y-" gradient lug was broken and loose from the terminal.The investigation concluded there were no witness (b)(6) on the "y-" lug mating surfaces or nut to indicate correct tightness.This is a unique situation potentially caused by interruptions on the build process leading to incorrect tightening of this gradient connection.This event has been shown to be an isolated incident.The customer site has been corrected and the system has been turned back over for clinical use.

• Brand Name: OPTIMA MR450W
• Type of Device: NUCLEAR MAGNETIC RESONANCE IMAGING
• Manufacturer (Section D): GE MEDICAL SYSTEMS, LLC; 3200 n grandview blvd.; waukesha, WI 53188
• Manufacturer Contact: jacqui budde ; 3200 n. grandview blvd.; waukesha, WI
• MDR Report Key: 8034854
• MDR Text Key: 126173824
• Report Number: 2183553-2018-00015
• Device Sequence Number: 1
• Product Code: LNH
• Combination Product (y/n): N
• Reporter Country Code: MX
• PMA/PMN Number: K123522
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/17/2019
• 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