MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. INGENIA 1.5T; SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING

Model Number	INGENIA 1.5T R5 BASED
Medical Device Problem Codes	Electrical Overstress (2924); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Convulsion/Seizure (4406)
Date of Event	10/06/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
In this case, the customer reported that lights flickering (ball lights) one section of the light bulbs has blown.The patient experienced an epileptic seizure.Philips has started an investigation of this complaint.
Additional Manufacturer Narrative
Philips has started an investigation.A follow up report will be send when the investigation has been completed.
Additional Manufacturer Narrative
The ambient ring, also known as the flare light, is primarily used for cosmetic and aesthetic purposes.It is controlled from the user interface module (uim) and can be switched on and off by the user according to the instructions for use(ifu).This incident was caused by the failure of one section of the light ring, flickering is a known failure mode and happens when the light(led) reaches the end of its lifecycle.In this case, the light source at site was over 3 years old, it was replaced before in 2020.Analysis of the replacement data has concluded that the failure rate is too high and not meeting expectations.Based on this a capa was initiated in which it was decided to initiate a field action covered in 2024-pd-mr-033.

• Brand Name: INGENIA 1.5T
• Common Device Name: SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.; high tech campus 36; eindhoven 5656A E; NL 5656AE
• Manufacturer (Section G): PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.; high tech campus 36; eindhoven 5656A E; NL 5656AE
• Manufacturer Contact: dusty leppert ; 222 jacobs street; cambridge, MA 02141
• MDR Report Key: 17994504
• Report Number: 3003768277-2023-05724
• Device Sequence Number: 6681011
• Product Code: LNH
• UDI-Device Identifier: 00884838055322
• UDI-Public: 884838055322
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K163116
• 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
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date (Section B): 07/01/2024

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 R5 BASED
• Device Catalogue Number: 781341
• 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: 10/06/2023
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/24/2023
• Supplement Report FDA Received Date: 07/01/2024
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 2024-PD-MR-033
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown