MAUDE Adverse Event Report: GE MEDICAL SYSTEMS, LLC SIGNA PIONEER; NUCLEAR MAGNETIC RESONANCE IMAGING

Device Problems Electromagnetic Interference (1194); Improper or Incorrect Procedure or Method (2017)

Patient Problems Laceration(s) (1946); Injury (2348)

Event Date 12/22/2019

Event Type  Injury  

Manufacturer Narrative

Age at the time of event: (b)(6).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 subcontractors were working to improve the shielding to the magnet scan room and were carrying a sheet of steel into the magnet room when it was attracted to the magnet.Two workers were seriously injured.Worker a sustained a laceration to his neck and was taken to surgery to close up the wound.He is recovering.The customer (b)(6) provided an updated status pending the completion of their investigation.This record will document the injuries for worker a.(2183553-2020-00002 will document the injuries for worker b).

Manufacturer Narrative

The investigation by ge healthcare has been completed.The incident occurred due to a lack of controlled access to the scan room by the gehc pmi (project manager of install) & failure of the subcontractors to follow verbal and written safety warnings in regards to ferrous material risks.The pmi was confirmed to have received the appropriate mr safety training and the ferrous object warning signs were present at the site.The mr service safety manual and installation manual clearly define the risks associated with entering the scan room with ferrous materials when the magnet is at field.

• Brand Name: SIGNA PIONEER
• 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: 9592535
• MDR Text Key: 175100131
• Report Number: 2183553-2020-00001
• Device Sequence Number: 1
• Product Code: LNH
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K160621
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/22/2019
• Initial Date FDA Received: 01/15/2020
• Supplement Dates Manufacturer Received: 03/21/2020
• Supplement Dates FDA Received: 04/17/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2019
• 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): Hospitalization; Life Threatening; Other; Required Intervention