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

Device Problems Unintended Collision (1429); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hemorrhage/Bleeding (1888); Complaint, Ill-Defined (2331); No Code Available (3191)

Event Date 04/06/2017

Event Type  Injury  

Manufacturer Narrative

Patient information could not be provided due to country privacy laws.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 a patient was brought into the mr room following an angio procedure.The patient had a bag on the groin area to apply pressure where the catheter had been placed.The bag was full of small magnetic balls and became attracted to the magnet.The bag struck the patient in the neck area and then the coil, damaging the coil to where the patient could not be scanned.The patient was not feeling well so was sent to the emergency room for follow up and then to ct for further diagnostic imaging.The patient was found to have blood leaking from one of the vessels in the neck which resulted in the patient undergoing surgery.

Manufacturer Narrative

Ge healthcare¿s investigation has been completed.The primary root cause has been determined to be inattentive behavior by the mr technologist by not removing the blood flow elimination weight bag prior to scanning the patient.The site opened an incident report for this event and has decided to remove magnetic weight bags from the hospital and to purchase new non-magnetic bags to eliminate similar incidents in the future.The site has been corrected as the ferrous object has been removed from the magnet.(b)(4).

• 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: 6549174
• MDR Text Key: 74583243
• Report Number: 2183553-2017-00007
• Device Sequence Number: 1
• Product Code: LNH
• Combination Product (y/n): N
• PMA/PMN Number: K123522
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Other Device ID Number: NOT APPLICABLE
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/22/2017
• 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
• Patient Outcome(s): Required Intervention