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U.S. Department of Health and Human Services

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

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GE MEDICAL SYSTEMS, LLC OPTIMA MR450W NUCLEAR MAGNETIC RESONANCE IMAGING Back to Search Results
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.
 
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Brand NameOPTIMA MR450W
Type of DeviceNUCLEAR 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 Key6562092
MDR Text Key75094722
Report Number2183553-2017-00008
Device Sequence Number1
Product Code LNH
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K113490
Number of Events Reported1
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
0 Patients were Involved in the Event:
Date FDA Received05/11/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received06/05/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/01/1970
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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