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

Model Number	INGENIA AMBITION X
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Tinnitus (2103)
Date of Event	06/04/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Philips received a report that a patient complained of excessive noise during a scan.Since that scan the patient reported ongoing tinnitus.
Additional Manufacturer Narrative
An analysis was done to determine the sound levels created by the system during the examination.The analysis showed that the noise level of the examination (extrapolated to a 1 hour examination) was 113,6 dba.The hearing protection provided to the patient was a headset that offers a damping of only 20 db in the 1 khz range.Earplugs were not provided as departmental stock was unavailable at the time.We therefore calculate with only 20 db damping from the provided headset.The attenuated noise level is (113,6 - 20) = 93,6 dba.This is within the limit of 99 dba as formulated in the iec60601-2-33 standard.Conclusion: reported incident was investigated, and no indication of a malfunction of the mr system was observed related to the sound levels.There is no evidence that the reported tinnitus is related to the mr examination.The patient baseline hearing status is not known.No audiogram results, reports by the audiologist or hearing tests have been provided.The current status of the patient's symptoms is not known.The most recent information available is that the patient continues to attribute ongoing tinnitus to the mri exam on 25/feb/2025.Since that time patient reported ongoing tinnitus.The patient has not provided any information about the treatment for the reported symptoms.

• Brand Name: INGENIA
• Common Device Name: SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
• 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: luis casillas lc ; 222 jacobs street; cambridge, MA 02141
• MDR Report Key: 25649701
• Report Number: 3003768277-2026-101203
• Device Sequence Number: 5877827
• Product Code: LNH
• UDI-Device Identifier: 00884838098350
• UDI-Public: (01)00884838098350
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K18479
• 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
• Report Date (Section B): 06/29/2026

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
• Operator of Device: Health Professional
• Device Model Number: INGENIA AMBITION X
• Device Catalogue Number: 782109
• 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: 06/04/2026
• Initial Report FDA Received Date: 06/29/2026
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male
• Patient Weight: 83 KG