MAUDE Adverse Event Report: GE MEDICAL SYSTEMS, LLC GE 1.5T SIGNA HDX MR SYSTEM; NUCLEAR MAGNETIC RESONANCE IMAGING

Device Problems Electromagnetic Interference (1194); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Injury (2348); Suture Abrasion (2497); No Code Available (3191)

Event Date 11/10/2017

Event Type  Injury  

Manufacturer Narrative

Patient information could not be provided due to country privacy laws.There are no additional device identification numbers.The initial reporter is located outside the u.S., and therefore this information is not 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 3rd party contractor brought a box of tools into the scan room during servicing.The contractor had been trained on mr safety, however did not check to see if the tools were mri safe.The box had ferrous tools which became attracted to the magnet.When this occurred, the contractor received an injury to the right hand.The right middle finger was fractured and received sutures, the index finger received a suture and the thumb sustained only a flesh wound.

Manufacturer Narrative

The investigation by ge healthcare (gehc) has been completed.The incident occurred due to inattentive behavior of the contractor by not checking the contents of the tool box prior to taking it into the magnet room.The contractor was mr safety trained and should not have brought the box of tools into the magnet room without first checking if they were mr compatible.Ferrous object warning signs were present at the site.No additional actions are required by gehc.(b)(4).

• Brand Name: GE 1.5T SIGNA HDX MR SYSTEM
• 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: 7073010
• MDR Text Key: 93419693
• Report Number: 2183553-2017-00027
• Device Sequence Number: 1
• Product Code: LNH
• Combination Product (y/n): N
• PMA/PMN Number: K052293
• 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: 01/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Other Device ID Number: UDI NOT REQUIRED
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/05/2018
• 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