MAUDE Adverse Event Report: PHILIPS ELECTRONICS NEDERLAND B.V. INGENIA 3.0T

Model Number	INGENIA 3.0T
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Tinnitus (2103)
Date of Event	07/20/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Philips received a report that a patient suffered from long term tinnitus after an mri examination.
Additional Manufacturer Narrative
A female patient had a cervical mri and after this she states she has hearing damage.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 114.7 dba.The earplugs provided by the hospital to the patient offers damping of 35 db.In addition the philips¿ headset with a damping of 20 db in the 1 khz range was used.It is therefore safe to calculate with at least 30 db damping.The attenuated noise level is (114.7 dba.¿ 30 db) 84.7 dba.This is below the limit of 99 dba as formulated in the iec60601-2-33 standard.There is no evidence that the onset of the hearing loss is related to the mr examination.It is known that the acoustic noise level of an mr system may be high enough to cause discomfort or result in temporary or even permanent loss of hearing when no adequate hearing protection is applied.The acoustic noise level of an mr system can also be one of the precipitating factors for the onset of tinnitus.Philips mr scanners fulfill the requirements as formulated in the iec60601-2-33 standard with respect to the allowed maximum acoustic noise production and are designed to be significantly quieter than the level set in this standard.Adequate hearing protection is necessary to prevent hearing complaints.The minimum level of protection is prescribed in the instructions for use (ifu): ensure to use acoustic damping of 30db or better.The ifu also states the special attention must be paid to patients to whom the headset or earplugs cannot be applied adequately.Furthermore, it stated that the operator should be trained to fit the earplugs properly.During all scans with a spl > 0 (as displayed on the info page), hearing protection must be used to comply with the requirements as formulated in the iec60601-2-33 standard.As most examinations do contain scans with a spl>0, hearing protection must be provided to all patients to prevent discomfort, temporary or even permanent loss of hearing.

• Brand Name: INGENIA 3.0T
• Common Device Name: INGENIA 3.0T
• 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 st; cambridge, MA 02141 ; 6172455900
• MDR Report Key: 15649808
• Report Number: 3003768277-2022-00598
• Device Sequence Number: 12285482
• Product Code: LNH
• UDI-Device Identifier: 00884838009813
• UDI-Public: 884838009813
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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,Followup

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: 10/07/2022
• Supplement Date Received by Manufacturer: 10/07/2022
• Initial Report FDA Received Date: 10/21/2022
• Supplement Report FDA Received Date: 12/20/2022
• 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 Age: 74 YR
• Patient Sex: Female
• Patient Weight: 68 KG