MAUDE Adverse Event Report: PHILIPS ELECTRONICS NEDERLAND B.V. INGENIA 3.0T; SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING

Model Number	INGENIA 3.0T
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/18/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Philips received a report in which a patient indicated a hearing issue, ringing/tinnitus, after an mr examination.As we have no info on the extent of the issue it was decided to report this out of an abundance of caution.
Additional Manufacturer Narrative
This report is based on information provided by philips field service personnel and has been investigated by the philips complaint handling team.Philips received a complaint on the ingenia 3.0t indicating that the patient reported ringing in the ears (tinnitus) as a result of the mr examination 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 96.6 dba.The hearing protection provided to the patient was a headset in combination with earplugs, that offers a total damping of 30 db in the 1 khz range.We therefore calculate with 30 db damping from the provided headset and earplugs.The attenuated noise level is (96.6 dba.¿ 30 db) = 66.6 dba.This is well within the limit of 99 dba as formulated in the iec60601-2-33 standard.There is no evidence that the reported tinnitus is related to the mr examination.Conclusion: reported incident was investigated, and no indication of a malfunction of the mr system was observed related to the sound levels.

• Brand Name: INGENIA 3.0T
• 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: 20577923
• Report Number: 3003768277-2024-06249
• Device Sequence Number: 8095888
• Product Code: LNH
• UDI-Device Identifier: 00884838009813
• UDI-Public: 884838009813
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K110151
• 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): 10/31/2024

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 3.0T
• Device Catalogue Number: 781377
• 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: 10/01/2024
• Initial Report FDA Received Date: 10/31/2024
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male
• Patient Weight: 88 KG