MAUDE Adverse Event Report: PHILIPS ELECTRONICS NEDERLAND B.V. INGENIA; SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING

Model Number	INGENIA 1.5T
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	09/11/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
Philips received a report on an attraction incident on an ingenia 1.5t mr system.A fire extinguisher was brought into the examination room, attracted to the magnet, injuring a user.

• Brand Name: INGENIA
• Common Device Name: SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
• Manufacturer (Section D): PHILIPS ELECTRONICS NEDERLAND B.V.; veenpluis 6; best 5684 PC; NL 5684 PC
• MDR Report Key: 10626054
• Report Number: 3003768277-2020-01007
• Device Sequence Number: 3368089
• Product Code: LNH
• UDI-Device Identifier: 00884838099715
• UDI-Public: 00884838099715
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K183063
• 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 1.5T
• Device Catalogue Number: 781315
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 09/11/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/11/2020
• Initial Report FDA Received Date: 10/05/2020
• 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: Other; Required Intervention