MAUDE Adverse Event Report: PHILIPS ELECTRONICS NEDERLAND B.V. INGENIA 3.0T

Model Number	INGENIA 3.0T R5 BASED
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	12/04/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
To prevent future incidents, we strongly advise to review the local procedure related to the (unauthorized) access to the controlled access area.Also, the mr staff must read and familiarize themselves with the safety chapter of the instruction for use.Other hospital staff that needs access to the mr examination room must also be mr safety trained.Ifu r5 section magnet safety - access to controlled access area.Warning: do not bring objects made of iron or other magnetic materials into the controlled access area.These objects will be attracted by the magnet and may lead to serious or fatal injury of the patient or operating personnel and may cause system malfunctions.Object examples: scissors, pocket knives, lighters, keys, coins, etc.Mobile phones and pagers.Vacuum cleaners, floor polishers, etc.Magnetic wheel chair, magnetic trolley, iron stretchers, etc.Mr unsafe fire extinguishers.Life supporting, vital sign monitoring, or emergency equipment such objects will be attracted by the magnet and may lead to serious or fatal injury of the patient or operating personnel and may cause system malfunctions.¿ a safety presentation is available on dvd, which explains the rf and other mri related safety issues: (b)(4), mr safety instructions.Clear user error.
Event or Problem Description
Philips received a report from a customer stating that a patient's leg was attracted in the magnet bore during an examination because of its metal implants.This resulted in the need for refixation of the patient's leg implant.

• Brand Name: INGENIA 3.0T
• Common Device Name: INGENIA 3.0T
• Manufacturer (Section D): PHILIPS ELECTRONICS NEDERLAND B.V.; veenpluis 6; best 5684 PC; NL 5684 PC
• MDR Report Key: 11864024
• Report Number: 3003768277-2021-10018
• Device Sequence Number: 19580754
• Product Code: LNH
• UDI-Device Identifier: 00884838055339
• UDI-Public: 884838055339
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K163116
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

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
• Operator of Device: Health Professional
• Device Model Number: INGENIA 3.0T R5 BASED
• Device Catalogue Number: 781342
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 04/25/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/25/2021
• Initial Report FDA Received Date: 05/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention