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

Model Number	INGENIA ELITION X
Medical Device Problem Codes	Insufficient Device Problem Information (3190); Device Handling Problem (3265)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/27/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Philips has started an investigation, a follow up will be submitted once complete.
Event or Problem Description
Philips received a report of an attraction incident with an anesthesia cart that was brought into the examination room.This caused extensive damage to the mr system and caused the patient support to topple over.There was no patient involvement.
Additional Manufacturer Narrative
The force of the impact of the anesthesia cart onto the patient support was of such extent that it exceeded the specifications 18.5 times.The impact force on the patient support was calculated at 74kn (74.000n).The interface between the patient support and the aluminum floorplate was still intact but the wooden floor to which the floorplate was connected became delaminated.There were no additional anchors used into the construction floor, however, these additional floor anchors would not have prevented the patient support from tipping over with such high impact forces.

• Brand Name: INGENIA ELITION X
• Common Device Name: SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
• Manufacturer (Section D): PHILIPS ELECTRONICS NEDERLAND B.V.; veenpluis 6; best 5684 PC; NL 5684 PC
• Manufacturer (Section G): PHILIPS ELECTRONICS NEDERLAND B.V.; veenpluis 6; best 5684 PC; NL 5684 PC
• Manufacturer Contact: dusty leppert ; 222 jacobs street; cambridge, MA 02141
• MDR Report Key: 18264888
• Report Number: 3003768277-2023-06713
• Device Sequence Number: 7890644
• Product Code: LNH
• UDI-Device Identifier: 00884838088115
• UDI-Public: 884838088115
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K173356
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: INGENIA ELITION X
• Device Catalogue Number: 781358
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/27/2023
• Supplement Date Received by Manufacturer: 11/27/2023
• Initial Report FDA Received Date: 12/05/2023
• Supplement Report FDA Received Date: 02/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown