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

Device Problems Disconnection (1171); Fire (1245); Loose or Intermittent Connection (1371); Smoking (1585); Arcing (2583)

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

Event Date 04/12/2017

Event Type  malfunction  

Manufacturer Narrative

Patient information has been requested but not yet obtained.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 that there was a thermal event that originated on the magnet room side of the penetration panel wall.A gradient filter box vibrated loose and disconnected causing arcing and inducing a fire on the pen panel.A patient was being scanned at the time when the mr technologist smelled smoke when he went into the room to move the patient.The technologist removed the patient from the mr scanner without incident, shut down the scanner and cut power to the system at the power distribution unit (pdu).The ge healthcare field engineer arrived onsite to assess the situation, replacing the gradient cables, penetration panel and other hardware.He performed safety and system checks and powered the system back up.No patient or healthcare workers were injured during this incident.

Manufacturer Narrative

Ge healthcare¿s investigation has been completed.It was concluded that the root cause of this incident was due to human error by the field engineer not tightening the brass nut on the x- terminal of the gradient filter box during system install.This caused arcing to occur while scanning which in turn led to combustion of a 3in.X 3in.Area of the acrylic plastic safety cover.The scanner indicated a fault condition to the operator.The operator tried to restart the exam, but the scanner¿s safety mechanism prevented that and shut the power to affected components down.The penetration box is accessible from the mr scan room and is not completely airtight.Some smoke/fumes escaped into exam room and the odor was noted by the patient.The exam was aborted and the patient was removed from scan room.A small flame within the enclosure area was discovered and extinguished by the rad tech.The facility¿s smoke and fire detectors and the sprinkler system in the scan room did not trip.Toxicology of the burnt acrylic plastic electrical safety cover and fire-retardant pvc gradient cable insulation material indicate that no toxic chemicals were released during the time of combustion.This event was an isolated incident and the root cause is not systemic.Therefore, no containment actions are warranted.Following the investigation, another risk review was conducted.This incident has been reassessed as a minor hazard.If this event were to recur, it is not likely to lead to a serious injury.

• Brand Name: OPTIMA MR450W
• 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: 6562092
• MDR Text Key: 75094722
• Report Number: 2183553-2017-00008
• Device Sequence Number: 1
• Product Code: LNH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113490
• 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: 06/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2017
• 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: 06/05/2017
• 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