MAUDE Adverse Event Report: GE MEDICAL SYSTEMS, LLC SIGNA INFINITY MR SYSTEM WITH EXCITE TECHNOLOGY; NUCLEAR MAGNETIC RESONANCE IMAGING

Device Problems Break (1069); Fire (1245); Smoking (1585); Arcing (2583)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/12/2019

Event Type  malfunction  

Manufacturer Narrative

There was no patient involvement.Unique identifier: udi not required.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 after an exam was completed, an mr technologist entered the magnet room and noticed a smell of smoke.The technologist removed the patient from the room and re-entered to see the glow of a flame underneath the rear covers of the mr system.The technologist used a non-ferrous extinguisher to put out the flame.The initial investigation found the heating occurred in an area of pinched and damaged cables under the scanner bridge.The patient was unaware of the issue, and no injury occurred.

Manufacturer Narrative

The investigation by ge healthcare (gehc) has been completed.The damaged cables were analyzed and it was verified that the arc occurred due to a crack in the drive cable shield.The crack was caused by a kink that resulted from the cable being pinched under the scanner bridge during prior third party servicing.The damaged drive cable created high voltage on the coaxial cable shield when transmitting power, which caused arcing.Polyethylene spiral wrap surrounding the cable briefly ignited due to the arcing.This event has been shown to be an isolated incident.The mr scanner has been corrected and the system has been turned back over for clinical use.

• Brand Name: SIGNA INFINITY MR SYSTEM WITH EXCITE TECHNOLOGY
• Type of Device: NUCLEAR MAGNETIC RESONANCE IMAGING
• Manufacturer (Section D): GE MEDICAL SYSTEMS, LLC; 3200 n grandview blvd.; waukesha, WI 53188
• MDR Report Key: 8776168
• MDR Text Key: 150688705
• Report Number: 2183553-2019-00013
• Device Sequence Number: 1
• Product Code: LNH
• Combination Product (y/n): N
• PMA/PMN Number: K013636
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 09/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1