MAUDE Adverse Event Report: GE MEDICAL SYSTEMS, LLC DISCOVERY MR750W 3.0T; NUCLEAR MAGNETIC RESONANCE IMAGING

Device Problem Arcing (2583)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/21/2020

Event Type  malfunction  

Manufacturer Narrative

No patient involved in this event.There are no additional device identification numbers.Unique identifier: (b)(4).Was this device serviced by a third party? unknown.Ge healthcare's investigation has determined that the cable mode present in the design of the mr750w rf body coil is the root cause of arcing that has led to excess heat/discoloration of the surface of the patient bore.Ge healthcare is initiating an action in the field to inspect units to determine which units have the potential cable mode, and make any corrections if necessary.This action was reported to the fda under correction number 2183553-06/13/18-002-c on (b)(6) 2018.Component code: (b)(4).

Event Description

It was reported that a customer called for service after noticing a brown spot on the bore at the completion of an exam.No patient injury occurred.

• Brand Name: DISCOVERY MR750W 3.0T
• Type of Device: NUCLEAR MAGNETIC RESONANCE IMAGING
• Manufacturer (Section D): GE MEDICAL SYSTEMS, LLC; 3200 n grandview blvd.; waukesha, WI 53188
• Manufacturer Contact: youssef halas ; 3200 n. grandview blvd.; waukesha, WI
• MDR Report Key: 10548949
• MDR Text Key: 207401512
• Report Number: 2183553-2020-00014
• Device Sequence Number: 1
• Product Code: LNH
• Combination Product (y/n): N
• Reporter Country Code: NZ
• PMA/PMN Number: K160618
• 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
• Report Date: 09/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/21/2020
• Initial Date FDA Received: 09/17/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/18/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: 2183553-06/13/18-002-C
• Patient Sequence Number: 1