MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. INGENIA; FULL-BODY MRI SYSTEM, SUPERCONDUCTING MAGNET

Model Number	INGENIA 3.0T R5 BASED
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Itching Sensation (1943); Confusion/ Disorientation (2553); Insufficient Information (4580)
Date of Event	07/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Philips received a report notification via the danish medicines agency.Problem description as follows: "the patient had an unpleasant experience during an mri scan on (b)(6) 2024.She felt dizzy and a burning sensation in her whole head and neck, eyes, face, and mouth.Tingling throughout her body, especially in her hands and arms.Itching all over her body.Involuntary twitching and tremors; inside the scanner, experienced a dry face, mouth, and eyes.After scanning, the patient felt confused, ended up in the wrong place, didn't feel that her brain was working, was forgetful afterward.Drained of energy, restless and stressed, itching throughout her body, especially in the neck.Burning sensation especially in the head and neck.2.Day, a lot of headaches and pain in the joints and muscles.Tension throughout her body.Itching and sleep disturbances.The 2 things haven't gone yet.Skin problems." it is not known if the patient's symptoms have fully resolved or, there was any treatment required.Based on the available information and out of abundance of caution, we decided to be reported this event.
Additional Manufacturer Narrative
Philips has started an investigation, a follow up report will be submitted once the investigation has been completed.Initial findings: based on available information, we could not confirm the system information (catalogue item identifier, serial number) other than it was ingenia 3.0 t.At this moment, we do not have confirmation that there is a philips system at this customer and if the customer information is correct.
Event or Problem Description
Philips received a report notification via the danish medicines agency.Problem description as follows: "the patient had an unpleasant experience during an mri scan in july 2024.She felt dizzy and a burning sensation in her whole head and neck, eyes, face, and mouth.Tingling throughout her body, especially in her hands and arms.Itching all over her body.Involuntary twitching and tremors; inside the scanner, experienced a dry face, mouth, and eyes.After scanning, the patient felt confused, ended up in the wrong place, didn't feel that her brain was working, was forgetful afterward.Drained of energy, restless and stressed, itching throughout her body, especially in the neck.Burning sensation especially in the head and neck.2.Day, a lot of headaches and pain in the joints and muscles.Tension throughout her body.Itching and sleep disturbances.The 2 things haven't gone yet.Skin problems." it is not known if the patient's symptoms have fully resolved or, there was any treatment required.Based on the available information, this issue has been determined to be a reportable event.
Additional Manufacturer Narrative
Based on the information available, the cause of the reported problem was not confirmed.To investigate the issue further additional information was requested from the provided contact.Unfortunately, despite several reminders, no additional information could be provided.This event is not assessable due to insufficient information the sequence of events and clinical information.A review of the risk management file was performed and it was concluded that the information provided is not sufficient to assess the risk of this incident.Additional findings: based on additional information received, the customer information and device identifiers (catalog item identifier) adjusted, and the device serial number added; customer information adjusted as well.

• Brand Name: INGENIA
• Common Device Name: FULL-BODY MRI SYSTEM, SUPERCONDUCTING MAGNET
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.; veenpluis 6; best 5684 PC; NL 5684 PC
• Manufacturer (Section G): PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.; veenpluis 6; best 5684 PC; NL 5684 PC
• Manufacturer Contact: dusty leppert ; 222 jacobs street; cambridge, MA 02141
• MDR Report Key: 23836176
• Report Number: 3003768277-2025-015800
• Device Sequence Number: 18458572
• Product Code: LNH
• UDI-Device Identifier: 00884838055339
• UDI-Public: 884838055339
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• PMA/510(K) Number: K163116
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/02/2026

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 Model Number: INGENIA 3.0T R5 BASED
• Device Catalogue Number: 781342
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/27/2025
• Supplement Date Received by Manufacturer: 02/16/2026
• Initial Report FDA Received Date: 12/18/2025
• Supplement Report FDA Received Date: 03/02/2026
• Was Device Evaluated by Manufacturer? (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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female